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  • Live Session
  • Recorded Session
Handling Garnishments and Abandoned Wages
The Consumer Credit Protection Act is designed to ensure fair and proper treatment of people with debts. Garnishment orders include creditor debt to child support.
Live Session Wednesday, September 3, 2014 09:00 AM PDT | 12:00 PM EDT, Duration:90 $179.00

Chemical Risk Management (CRM) to improve Environment, Health and Safety
CRM is as a process by which chemical risk management options (RMOs) are identified, prioritized, and implemented to ensure Environment Health and Safety (EH & S).
Live Session Wednesday, September 3, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $141.00

GMP (Good Manufacturing Practices) for Food Manufacturers
Good Manufacturing Practices always going to be a hot topic: Every food manufacturer needs to comply with this basic regulation. It is fundamental for the construction of a food safety system in the manufacturing process. GMP is a standard which covers the manufacturing of packaging made of corrugated and solid board in order to fulfill legal requirements according to EU regulations 1935/2004/EG for food contact materials.
Live Session Thursday, September 4, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $179.00

Project Management for Computer Systems Regulated by FDA
Project management principles can be used to ensure that all efforts to develop, configure, implement, test, validate and maintain a computer system is compliant.specific in terms of how this is to be done.
Live Session Thursday, September 4, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $179.00

An Advanced course on Lean Documents and Document Control
In this Lean Documents and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.
Live Session Friday, September 5, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $206.00

Employee Fraud Awareness Training
Fraud detection and prevention depends on numerous factors— none more significant than employee tips. However, tips only are reported if employees know what to look for. To optimize your organization's employee fraud tip reporting, it is therefore essential to have a robust awareness training program in place.
Live Session Tuesday, September 9, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $179.00

E-Compliance: Know Your Rights and Obligations on the Internet
This webinar will focus on the Internet- based compliance issues that cause businesses and Internet users concern regarding data privacy and security, taxes.
Live Session Tuesday, September 9, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $179.00

Secrets of Affirmative Action Compliance
Like all US employers, federal contractors should have recruitment, hiring and employment practices which ensure equal opportunity on the basis of gender, race, color, religion, national origin, disability or status as a protected veteran. For Contractors, however, there are two additional issues in that they must be proactive in ensuring equal opportunity and severe judgments can be levied against them for failure to do so. The OFCCP's regulatory agenda demonstrates that the OFCCP intends to aggressively enforce the laws under its jurisdiction and to strengthen the regulations that implement those laws. Moreover, all of the developments over the last four years reflect the OFCCP's recently stated belief that affirmative action can no longer be measured by good faith efforts. Indeed, both proposed and implanted changes to compliance requirements reflect a push by the OFCCP for federal contractors to engineer results.
Live Session Tuesday, September 9, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $151.00

Best safe work practices for preventing Slips, Trips and 5S Technique, Checklist
Same level slips, trips are occupational hazards that can be found in almost every type of work setting. It is estimated that more than 2 million disabling work injuries are caused each year by slips and trips, accounting to 7-10 percent of all workers' compensation costs.
Live Session Tuesday, September 9, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $179.00

Processing Individual Case Safety Report (ICSR): workflow in Pharmacovigilance Industry
This webinar will describe how to process Individual case safety reports (ICSR) from different sources in pharmacovigilance operations from compliance, and safety perspectives. A structured methodology for case processing and reporting in drug safety operations will be presented. The webinar will also cover the process of adverse reporting for pre- and post-marketing cases including different steps like Case Intake, Case Processing, Medical Assessment and Distribution/Submission. This would be highly effective, as participants will get an opportunity to learn about case studies to manage a safety data crisis.
Live Session Tuesday, September 9, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $179.00

Health Record Documentation Excellence
Clinical documentation integrity is paramount for accurate code assignment, quality reporting and continuity of care. Join us as we share some insight into:
Live Session Wednesday, September 10, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $151.00

The Sunshine Act Reporting for Clinical Trials
Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare. Under the new rules, principal investigators and co-investigators are subject to unprecedented disclosure requirements to the Center for Medicare and Medicaid Services (CMS).
Live Session Wednesday, September 10, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $206.00

Advances in vision guided robots technology and their impact on precision products for the medical industry
This Webinar focuses exclusively on the successful implementation of vision guided robotics for device industries. It will also discuss advances in robotic technology and machine vision and the impact on medical device manufacturing for the orthopedic industry.
Live Session Wednesday, September 10, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $212.00

Avoiding the Legal Pitfalls from Screening Applicants
The webinar talks about laws to be considered in employee recruitment. The laws include Title VII, Americans with Disabilities Act, Fair Credit Reporting Act.
Live Session Thursday, September 11, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $149.00

Effective Business Writing for Financial Professionals
This webinar guides you in writing clear, concise, and powerful financial documents. A must for any professional who works in the finance industry.
Live Session Thursday, September 11, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

1099 & W-9 Update - Complying with IRS Information Reporting
What are the rules regarding paying and IRS reporting on Independent Contractors?How do we avoid the IRS CP-2100 (B-Notices)?What if our vendor/payee claims exemption; must I obtain a W-9 anyway?What are the best practices for handling our information reporting obligations?How can we minimize risk of improper exemption claims by my vendors?Get the answers to these and related questions to reduce your risk of huge penalties from the IRS.
Live Session Tuesday, September 16, 2014 09:00 AM PDT | 12:00 PM EDT, Duration:90 $199.00

Working with an auditor in a regulatory inspection
This webinar will talk about the important structure of a regulatory agency's inspection and the vital behaviors required for ensuring that right information is presented during a quality audit. Proper record keeping and documentation will be discussed along with how best to cite and prepare summaries of the observations. An evaluation of System Based Inspections and how to determine your weakness to avoid FDA-483 issues will also be discussed.
Live Session Tuesday, September 16, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $249.00

Taking the Mystery out of Environmental Requirements
The mystery is associated with what are the requirements for a facility/company, when do they apply, are there any exceptions and do the exceptions apply to any company operation, what are the reporting requirements and when and how do they apply? How does a facility keep up with ever changing requirements? and many more. Many have struggled with environmental requirements and how best to take away the mystery associated with them.
Live Session Tuesday, September 16, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $149.00

Common Employer Strategies for Avoiding or Minimizing Penalties Under Health Care Reform
Under health care reform, large employers, which do not offer health coverage to all full-time employees, will be subject to penalties, beginning in 2015.
Live Session Tuesday, September 16, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

Employee Travel Pay - Right Handling
This webinar concentrates on the requirements under the Fair Labor Standards Act (FLSA) of when to pay employees for traveling, how to handle travel pay rightly.
Live Session Wednesday, September 17, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

21 CFR 820 (The QSR) – A practical approach to what each subpart really requires
This webinar will focus on 21 CFR, FDA 483 and warning letter observations to understand the FDA's intent when reviewing your company's quality system.
Live Session Wednesday, September 17, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

Supply Chain Auditing for Gas, Electric Utilities and Petrochemical companies
Earlier internal audit viewed supply chain and procurement processes only periodically. Now with the ever changing global economy, ensuring effective and efficient running of your supply chain is of paramount importance.
Live Session Wednesday, September 17, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $199.00

Justifying Safety Expenditures
Often companies make the decision to include Behavior Based Safety in their safety management process and begin the journey with some early successes and a lot of momentum. Unfortunately they frequently find that after several months their successes are becoming fewer and the momentum is slowing down. In fact, people are actually disengaging from the effort.
Live Session Wednesday, September 17, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:60 $149.00

Auditing API Facilities
Auditing an API Facility is not a "walk in the park". One needs to really learn API GMP and where and what to look for during an audit. Recent publicity surrounding API manufacturing and testing sites, have illustrated how poorly too many API facilities are performing during regulatory inspections. The deficiencies that are now being identified exist in spite of previous audits and regulatory inspections. Many, if not all of the major deficiencies did not just happen. These deficiencies have likely existed for a long time and this webinar program will help interested parties be better prepared to audit these facilities.
Live Session Wednesday, September 17, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $249.00

Investigating Workplace Bullying Claims
Bullying can deter talented employees from joining the company, minimize their performance, increase absenteeism and hasten their departure, this is a big issue.
Live Session Wednesday, September 17, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:60 $159.00

Fundamentals of the new FDA inspectional record requirements for EDC and EDE clinical trials
This webinar deals with basics of new FDA inspectional record requirements for EDC/EDE clinical trials. Case history of multiple site trial that uses EDC to be presented. For electronic record function procedures, changes might be possible to remain in compliance with the compliance inspectional standards.
Live Session Thursday, September 18, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

Healthcare Quality Improvement Act - Achieving Immunity in Your Peer Review Process
This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity under the act. The Health Care Quality Improvement Act of 1986 is, apparently, meant to save the public from incompetent physicians by permitting those physicians on peer review committees to exchange a few words in an open and honest environment and thus pull out incompetent physicians, without the presence of a retaliatory lawsuit by the reviewed physician. The webinar will also review the HCQIA itself, including a detailed look at the Congressional purpose for the Act. The legislative history of the act will be reviewed to gain an understanding of the intent of Congress in passing the Act.
Live Session Thursday, September 18, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

Trade Services - US trade partners and patterns and common methods for conducting international trade
Participants will learn about US trade partners and patterns and why companies engage in international trade. We will cover various trade instruments and will discuss briefly about the financial supply chain.
Live Session Thursday, September 18, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

Protecting against Competitive Intelligence - Broadened Approach to Corporate Security
This webinar speaks about what is competitive intelligence and highlights the key elements of developing and running one's own program to protect competitively sensitive information from other competitors who use competitive intelligence to capture it.
Live Session Thursday, September 18, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

FDA Regulation on Tobacco Products, Deeming regulations and Impact on E-Cigarettes
The webinar on FDA Regulation on Tobacco Products, Deeming regulations & Impact on E-Cigarettes will mainly focus on Tobacco Control Act, impact of tobacco products.
Live Session Friday, September 19, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

Designing for Safety to avoid Automobiles Recalls
Over 30 million automobiles have been recalled in recent years involving the top companies including Toyota, GM, Honda and Ford. The problem is often the flawed specifications, flawed production requirements, and lack of system integration.
Live Session Friday, September 19, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

Union Avoidance Policies
Join this webinar to learn about whether your organization is a potential high conflict "hot spot" and steps you can take to create the type of work environment where employees and the business flourish without the labor union involvement. Section 7 of the National Labor Relations Act (NLRA) gives employees the right to form labor union giving them the ability to unionize or not to unionize.
Live Session Tuesday, September 23, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $143.00

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.
Live Session Tuesday, September 23, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $243.00

Understanding FDAs Recent 510(k) Guidance and New Requirements
This webinar is intended to discuss the recent changes, hurdles, and requirements for premarket notification [510(k)] compliant with eCopy and Refuse to Accept Policy (RTA) requirements.
Live Session Wednesday, September 24, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

Establishing a Reduced Testing Process for Incoming Materials
The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process.
Live Session Wednesday, September 24, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $199.00

Fraud Risk Assessment – Its about more than 'Minding the Fraud Gap'
This course is designed to assist those responsible for fraud risk management in their organisations in setting the scene for an effective Fraud Risk Assessment and the considerations to undertake in achieving the objectives of one.
Live Session Thursday, September 25, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

Designing and Administering Fair and Effective Discipline and Discharge Policies
One of the most unpleasant and sometimes one of the most difficult tasks for any manager is disciplining or discharging an employee. Devising a fair and equitable discipline and discharge policy is a challenge in and of itself, but administering that policy can sometimes be a stressful and exasperating experience. Beyond the personal experience of the managers involved, improperly disciplining or discharging an employee can subject an employer to charges of discrimination. It would be wonderful if all employees acted like responsible adults all of the time, but unfortunately that is not the reality in the work world.
Live Session Thursday, September 25, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:60 $149.00

Application of HACCP Analysis in the Food Industry
This webinar will provide you with an overview of the seven principles of Hazard analysis and critical control points (HACCP) and its application in food process for the development and implementation of HACCP guidelines for food safety. Hazard Analysis Critical Control Points (HACCP) is a key element to secure that the food products produced and offered to consumers are safe. HACCP is a methodology that helps to identify biological, chemical and/or physical hazards in the processing of foods, establish monitoring methods to effectively control hazards and have the adequate response to any corrective action.
Live Session Thursday, September 25, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

Medical Device Employee Training - Requirements and Implementation Tips
This presentation will provide information and tips on best practices for assuring your employees are properly trained. Improperly or inadequately trained employees lead to both product and process nonconformities.
Live Session Thursday, September 25, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

NQA-1 for non-QA Audit Personnel
ASME NQA-1 is the national consensus standard for quality assurance (QA) programs at nuclear facilities and power plants regulated and licensed by the Nuclear Regulatory Commission (NRC). The NQA-1 standard is also a QA program requirement at U.S. Department of Energy (DOE) nuclear and radiological facilities. NQA-1 is not just a standard for QA to perform compliance audits; it is a comprehensive quality management system that governs nuclear-related job functions and activities.
Live Session Thursday, September 25, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $199.00

In-Depth Testing for Computer Systems Regulated by FDA
This course is intended to provide specific guidelines for developing an approach for in-depth testing of computer systems regulated by FDA. These include, but are not limited to system implementations, migrations, integrations, upgrades and retirement.
Live Session Thursday, September 25, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:60 $199.00

CE Mark - Required to Sell in the European Market
Medical devices sold into the European Union (EU) must comply with the applicable medical device directives, EU laws similar to FDA's regulations. Medical devices declared compliant must bear a CE mark in order to be admitted into the 29 member countries comprising the EU. The market population of these 29 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman's terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC.
Live Session Thursday, September 25, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

Improved Thoughts, Policies and Training Protocols on Workplace Hostility
While workplace homicides have dwindled by more than 50%, the level of hostility and harassment continues to rise. As the workplace becomes increasingly more diverse, HR and other department heads must pay superior attention to mitigating a wide range of hostile behaviors.
Live Session Monday, September 29, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $149.00

Mathematics of Terminal Sterilization - Probability of Survival Approach vs Overkill Approach
Heat sterilization is a PROBABILTY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenterals and medical devices.Since Regulations require that we generate in our sterilization processes a PROBABILITY of a NON-STERILE UNIT (PNSU), how do we use D-values, Z-values and Fo to calculate the probability and determine that we have essentially zero risk in our products due to lack of sterility?
Live Session Tuesday, September 30, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $243.00

Handling Difficult Employees and Situations of Internal Investigations
Employers conduct investigations for a variety of reasons; employee complaints, background checks, allegations of misconduct, losses of various types. The shared primary purpose of these investigations is the same - to find out the true facts of a situation to determine a course of action to take - or to not take.
Live Session Tuesday, September 30, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

Ready-to-eat Foods - Pathogens of Concern and Intervention Controls
Consumer demand for minimally processed products with a longer shelf-life has resulted in the mass production and distribution of chilled convenience ready to eat (RTE) foods. However, ready to eat foods remain a significant vehicle for foodborne pathogens such as Listeria monocytogenes. The challenges are enormous because production of ready to eat foods frequently involves extensive processing and packaging. Therefore, this webinar is designed to review current knowledge on the pathogens of concern, sources and intervention controls.
Live Session Tuesday, September 30, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $199.00

Developing a Validation Master Plan
This course will provide a step-by-step guidance for medical device companies that need to develop a Validation Master Plan (VMP) for product/equipment transfer, facilities, and processes or to develop a company standard.
Live Session Tuesday, September 30, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $243.00

Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production
Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced.
Live Session Tuesday, September 30, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

Using Excel Spreadsheets in FDA Regulated Environment
Excel spreadsheets are easy and convenient to use for handling common data capture and analysis functions. FDA accepts data in Excel spreadsheets provided it meets the criteria of confidentiality and integrity defined within 21 CFR Part 11, GAMP 5 and related regulations. Excel can be made FDA compliant with simple procedures and practices to meet regulatory requirements. This seminar provide insight into regulatory requirements and inherent limitations in “Out of the Box” Excel, validation techniques, documentation requirements, and risk-based evaluation of Excel spreadsheets. Practical strategies and case studies will be used to highlight common issues and potential solutions.
Live Session Wednesday, October 1, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

Hazardous Waste Management
Waste that causes potential threats to public health or the environment is called Hazardous Waste. In the United States, the treatment, storage and disposal of hazardous waste is regulated under the Resource Conservation and Recovery Act (RCRA).
Live Session Wednesday, October 1, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

Electrical Safety Work Practices: High Voltage for Qualified Person
This import compliance webinar will help you understand the basic electrical safety work practices of the OSHA's 1910.269 standard and National Electric Safety Code (NESC).
Live Session Thursday, October 2, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $199.00

Items to Consider When Negotiating Physician Employment Agreements
We will review the various elements of the physician employment agreements, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Items such as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are items that should be clearly set out in the agreement and fully understood by the parties.
Live Session Thursday, October 2, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

The EHS business plan: Creation, Implementation and Management
The webinar will focus on moving the thinking of EHS management to a business approach. The change will help create proactive rather than reactive thinking and behaviors for those involved in EHS management.
Live Session Tuesday, October 14, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $149.00

Developing Training Programs for employees
Although technology-based training is becoming increasingly popular, training experts agree that it will never completely replace conventional trainings. At present, an overwhelming number of companies continue to use training alongside an increasing amount of technology-based training, such as e-learning and computer-based training.
Live Session Wednesday, October 15, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $159.00

Upgrade your marketing strategy with competitive intelligence
This webinar highlights the key elements of how competitive intelligence techniques and personnel can power the development and execution of your marketing strategy.
Live Session Wednesday, October 15, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

Functions, Procedures and Permits of COFEPRIS & SENASICA - Agencies Regulating Fresh and Processed Foods in Mexico
To describe the main functions and scope of action of COFEPRIS-SS and SENASICA-SAGARPA. These are the two main agencies in the regulation of fresh and processed food products in Mexico. The food products are regulated depending on the type of product (processed or fresh) and the category (food, non-alcoholic beverage, dietary supplement, etc.). It is vital to understand the steps and procedures to be performed for marketing of the food products to be in compliance with Mexican regulations.
Live Session Tuesday, October 21, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

Lets Get Back to the Basics of Withholding, Depositing and Reporting Federal Taxes
This webinar covers the basics of withholding, depositing and reporting federal taxes including how to obtain an employer identification number, the types of withholding methods available for federal income tax and how to calculate FICA taxes. It will cover step-by-step the calculations for determining the proper income tax withholding including when to use the supplemental rate. Will also cover FICA taxes and how they are affected by totalization agreements (US citizens working abroad) and nonresident aliens (non-US citizens working in the United States). It will also cover the calculation of FUTA taxes including the effects of the credit reduction states. For those employers affected by them, the webinar will cover rules for basic rules for successor employers and common paymaster.
Live Session Friday, October 24, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $179.00

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
This presentation will provide information on how to review your current risk analysis to make sure you fully comply with the requirements for Risk Analysis under EU Directive 93/42/EEC on Medical Devices and the other European Medical Device directives. The stricter interpretations will be expected during ISO 13485 audits and Technical File and Design Dossier document review starting in 2013. You cannot depend that you can meet these requirements just because your current risk analysis meets ISO14971:2007, unless you are fully aware of the implications of ISO14971:2012.
Live Session Thursday, October 30, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

Major Air Pollutants
Attend this webinar to learn Major Air pollution rules and regulations, requirements and procedures for reviewing and issuing air pollution control permits to all new major stationary sources and all major modifications to major sources located in attainment or unclassified areas.
Live Session Tuesday, November 4, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

Controlled Document System for Life Sciences manufacturing plant - principles of Lean Documents and Lean Configuration
This webinar explains about Controlled Document System for Life Sciences manufacturing plant - principles of Lean Documents and Lean Configuration in Manufacturing.
Live Session Tuesday, November 4, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

Overview of the Mexican Labeling Standards and the New Labeling Requirements
To know and understand the Mexican labeling standard as well as and the new requirements regarding the use of Front of Pack icons and the voluntary request of a nutritional Logo.
Live Session Tuesday, November 11, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

How to effectively manage an EHS program at the international level
The course is designed to provide insights on how to manage an EHS program on a global basis. It will address the difficulties of managing different cultures, and how best to integrate these cultures to add value to an organization.
Live Session Tuesday, November 11, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $149.00

Things to know when Working with Compendial (USP) Procedures
Documentary standards published in the US Pharmacopeia-National Formulary (USP-NF) are recognized as the legal standards for prescription and non-prescription medicines distributed in the United States. They contain required information for compendial testing identity, strength, quality, purity, packaging, prescription labels and drug warning labels of compendial products. These monographs are included for drug products, drug substances, veterinary products, excipients, dietary supplements, compounding preparations and more. In addition, there are important sections, including General Notices and General Chapters to guide acceptable practices when working with compendial testing procedures.
Live Session Wednesday, November 12, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $249.00

21 CFR Part 820 : Applying Principles of Lean Documents and Lean Configuration
To present a fresh approach to following 21 CFR Part 820, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration in this webinar.
Live Session Wednesday, November 12, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $243.00

Wage and Hour Audits
Due to pressure from political influences, the need for increased tax revenues, and possibly due to concerns over illegal immigration, the U.S. Government has stepped up enforcement activities of various targeted industries, including the hotel and hospitality industry. The Wage and Hour Division of the U.S Department of Labor has the authority to conduct investigations in a particular industry or locality, especially when there are indications of widespread violations. Under the Obama administration, the Wage and Hour Division (WHD) of the U.S. Department of Labor (DOL) has become re-energized and is the most active.
Live Session Wednesday, November 12, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $159.00

FDA Food Safety Modernization Act: A Primer by FDA
The FSMA (Food Safety Modernization Act) was signed into law by the President Obama on January 4, 2011. This law establishes new responsibilities for companies that export products to the US along with other provisions for local companies. This is a general overview of the FSMA.
Live Session Thursday, December 4, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

Forecasting with Excel's Powerful Sensitivity Tools
Financial Modeling is based on the idea that forecasts are subject to variation and this variation should be tested and communicated as an aide to effective to decision making. Attend this briefing on Excel to unleash its powerful sensitivity tools. Get the full power out of your financial models. Improve the design of your models to take advantage of these tools in just 90 minutes.
Live Session Wednesday, December 10, 2014 09:00 AM PDT | 12:00 PM EDT, Duration:90 $199.00

Life Safety Code Fundamentals for Healthcare Facility Professionals

Existing healthcare occupancies (hospitals, nursing homes, limited care facilities, etc.) are required to comply with NFPA 101 Life Safety Code (LSC) by the Centers for Medicare & Medicaid Services (CMS), States and local building codes. This webinar describes and explains key LSC health care occupancies (code sections 18 and 19) requirements that are important to maintain a safe environment for your staff and patients against loss of life due to a single source fire event.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Employee and General Workplace Investigations

Training on effective and lawful workplace investigations are essential for all human resources managers and others charged with this responsibility. The need to conduct a workplace investigation may arise when a complaint is made by or against an employee. This webinar will offer guidance on how to proceed and how to achieve a meaningful outcome for all involved. When it comes to employee investigations, it's all about the 'W's - Who, What, When and Why. Asking crucial questions, seeking key information and documenting your findings make a big difference in conducting successful investigations. In this webinar, we discuss the techniques for conducting investigations, interviewing parties and documenting information and findings.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Latest Developments and Strategies in Family and Medical Leave Act (FMLA)

This webinar will talk on developments in Family and Medical Leave Act and suggest strategies to avoid employee abuse. Firms with above 50 workers are subject to FMLA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Best Practices For Responding to Organizational Traumas, Tragedies and Transitions

This webinar will give you better insight on Best Practices For Responding to Organizational Traumas, Tragedies and Transitions. This program will provide “nuts and bolts” strategies and services to maintain organizational resilience during and after a crisis.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

How to legally use background checks to avoid the EEOC

Equal Employment Opportunity Commission (EEOC) enforces federal laws against employment. This permits employer to do a background check before hiring an employee.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Analyzing The Risk Management - Competitive Intelligence Link

This webinar highlights the key elements of linking competitive intelligence techniques and teams to improve your existing risk management efforts - and vice versa. Competitive intelligence has become a powerful tool to assist businesses and even non-profits to compete more effectively. However, even the institutions that use CI most effectively often fail to utilize CI and CI techniques in their risk management programs. This webinar will help remedy that.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

FDA Guidance on Mobile Medical Apps

The FDA's recent guidance on mobile medical apps addresses different regulatory requirements for categories of apps and coupled equipment. This course will provide a practical overview of mobile medical app regulations including examples of devices and companies that have gone through the process. Review differences between mobile medical apps regulated by FDA discretion/ un-regulated. Explore regulatory filing strategies with case studies and innovative approaches to mobile health products. The FDA supports the progress of mobile medical apps that betters healthcare and supplies consumers and healthcare professionals with precious health information. The FDA also has a public health responsibility to manage the safety and efficacy of medical devices - including mobile medical apps.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

FATCA (Foreign Accounts Tax Compliance Act) – How to Comply with Minimal Withholding, Tax and Penalty Impact

US authorities are determined to uncover hidden accounts of US persons holding assets abroad and ensure they are properly taxed. Learn about this complex law, the various types of agreements required to be executed between the IRS and foreign entities and foreign financial institutions, the account review requirements, the grandfather provisions and the reporting provisions of this new law.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Handling Payroll Overpayments Correctly

This webinar discusses the issues that arise when an overpayment has been made in the payroll department. It addresses the requirements that must be followed for recouping the overpayment under IRS and wage and hour regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Workplace Civility - Respectful Habits Lead to Increased Productivity, Decreased Liability

Today organizations are realizing the tremendous cost of incivility in the workplace. Incivility leads to decreased morale, anxiety, depression, absenteeism, and loss of productivity. Employees working side-by-side need to learn how to respect each other so they can work as a team. In this information-packed webinar, Judi Clements shows you how to begin the process of making your organization a civility-conscious place.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $193.00

How sponsors generate GCP noncompliance at their investigator sites

This course will demonstrate that many of the 21 most common FDA observations of noncompliance at investigator sites relate, not only to the investigator, but directly to sponsor clinical research and clinical operations procedures. Multiple case history examples will be discussed. Many of these observations of noncompliance could have been prevented or remediated by appropriate sponsor procedures if they had been applied to the investigator's conduct of the clinical trial.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Developing Sound Human Resource Policies in an organization

Every employer aspires for an organization that is safe, fair, efficient, and friendly with productive employees. Yet, they cannot rely on every employee to be "on the same page" with respect to job performance and behavior at the work place nor understand the legal aspects in certain situations. As such, the employer would want to have policies in place to serve as a standard for expected and accepted behavior. Do the policies have to cover every conceivable circumstance and individual situation? Couldn’t that become prohibitively cumbersome? What about management discretion? Where to begin?
Recorded Session Access recorded sessions unlimited viewing for 6 months. $193.00

Corrective And Preventive Action (CAPA) - Root Cause Analysis, Problem Solving

This webinar will present CAPA regulatory requirements and effective problem solving methods for device, manufacturing and quality system problems.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Software Validation- Avoiding FDA Warning Letters and Consent Decree

Computerized manufacturing and quality systems are cited by FDA auditors to be poor in adequate validation leading to FDA 483s, Warning Letters and Consent Decrees.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Introduction to the Occupational Safety and Health Act (OSHA)

This program provides attendees with a practical introduction to how OSHA works, focusing on what prompts an OSHA inspection, how to prepare for an OSHA inspection, how to handle an inspection, and the choices presented to employers once an OSHA Citation is issued.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Why initial attempts at Behavior Based Safety Fail

Learn more about Behavior Based Safety, the barriers in implementing and establishing a Behavior Based Safety system in an organization from this webinar.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Vaginal Microbicides- A Wearable Intravaginal Ring To Protect Against HIV Infection

This webinar is intended to discuss vaginal microbicides. FDA defines vaginal microbicides as intravaginal drug products that reduce the risk of HIV acquisition. Microbicides are applied to rectal or genital mucosa against HIV infection. Microbicides are intended to block HIV at the portal of entry, and directly at the mucosal level through delivery of high drug concentrations locally. Vaginal microbicides are designed to be self-administered products. Microbicides can be developed as vaginal formulations such as gels, creams or film, tablets, intravaginal rings (IVRs) impregnated with active product, condom impregnated with active product, etc.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Run a Compliant HR Department Without a HR Person

Businesses reach a point that they need someone to handle their HR functions. However many businesses hire a HR person before they really need one. Trying to find a HR person to fit into a small budget can recruit unqualified persons.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

US, EU and Japan GMP Requirements- Practical ICH Area Differences and Healthcare Inspection Focus

This webinar reviews the latest developments in ICH Q7 GMP harmonization between US, EU and Japan. It describes how the advent of this guidance impacts the different countries and explains why the regulatory authorities of each country, still have divergent expectations, despite the harmonization. It then explains how to overcome the differences in the expectations of the US, EU and Japan regulatory authorities, to ensure successful inspections with minimum additional cost or effort.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Legal, Regulatory and Policy Issues Related to Computer System Validation as the FDA Regulates Tobacco Products

We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process), specifically as it relates to the tobacco industry. Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
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The Use of Leading Indicators to Project Future Safety Performance

The Heinrich Safety Pyramid identifies a relationship among severity of injuries. The greater the severity, the lower the number of injuries expected. The near the bottom of the pyramid are the first aid injuries. There is a level of the pyramid below first aids. It is the base of the pyramid and it contains "Leading indicators." These include, among others, unsafe acts, unsafe conditions and near misses. While this is the richest area of safety information, it is generally not used to its full value. Through this webinar you will learn how to use data from the base of the pyramid to project future injuries.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products

Companies manufacturing products derived from human cells and tissues for autologous implantation, transplantation, infusion or transfer of human cells and tissues for therapeutic purposes are allowed to market their products without a formal marketing approval under a BLA provided they meet certain conditions that define the permitted good manufacturing and tissue handling practices, labeling and shipping, inter-state commerce and marketing claims. Products that do not meet the strict criteria set by FDA are subject to the IND and BLA regulations before being allowed to market. Recently FDA issued Warning Letters to some companies marketing HCT/Ps citing major modification to human cells and tissues and asked to initiate a formal investigation under an IND and marketing approval. Some products have even been withdrawn from market due to FDA action.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Build an Anti-Fraud Culture-Going BEYOND Just Ethics

If yours is like most organizations, it has a well-crafted ethics policy as well, perhaps as a formal compliance policy. These are important for building a "corporate culture" of integrity and honesty. However, they generally do not go far enough when it comes to reducing the organization's risk of fraud. And fraud, after all, is among the most damaging threats to high standards of business integrity.
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Purchasing Card Compliance with IRS Guidelines

This webinar highlights the evolution of IRS involvement in the use of credit cards for business use, more commonly referred to as Purchasing Cards. As usage has increased in recent years so has the governance of these transactions. Many changes have occurred or been proposed that haven’t been as publicized as needed so many companies are left wondering. The goal of this webinar is to help uncover some of these changes so your business can operate optimally in the credit card space.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Cyber Fraud: The New Financial Crime Wave

It seems like every time we turn on the news there is a report of a new breach or potential breach. This course will hit on some of the main areas at risk and processes organizations are putting in place to safeguard against these attacks. The use of Internet services or software with access to Internet to defraud victims or to otherwise take advantage of them, for example by stealing personal information, which can even lead to identity theft. A very common form of Internet fraud is the distribution of rogue security software. Internet services can be used to present fraudulent solicitations to prospective victims, to conduct fraudulent transactions, or to transmit the proceeds of fraud to financial institutions or to others connected with the scheme.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Preparing for FDA Inspection and Management including GLP Inspection: Best Practices

This webinar is intended to help you get familiar with FDA Good Laboratory Practice (GLP) Inspection and Preparation – Dos and Don'ts. This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don'ts before, during and after the FDA GLP inspection will be discussed.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Food Laws and Regulations in Mexico

There are several regulations to accomplish in order to export and market food products in Mexico. Those regulations are being amended to secure healthier foods for the Mexican population. Labeling as well as import/export regulations are key elements to successfully market food products in Mexico. The best method to avoid trade impediments at the border before exporting products to Mexico is to locate an experienced Mexican customs broker. These brokers are authorized by the Mexican Internal Tax Registry to handle customs clearance operations. The Mexican government publishes technical regulations) or standards often referred as NOM, in the Diario Oficial de la Federación (Official Gazette) - the Mexican equivalent of the U.S. Federal Register.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties

Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements. Understand the difference between and 1st and 2nd B-Notice and the related differences in required vendor responses. Be sure you institute and stop Backup Withholding when required. Join us for a content-rich 90-minutes and you will gain the tools to make you the most effective information return manager your company has ever seen.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Project Management for Human Resources Professionals

This webinar guides you through the process and provides you tips to improve and strengthen your project management skills. The purpose of this session is to provide you with the skills, knowledge, and tools to effectively and efficiently define, organize, plan, manage, and close human resource related projects. A professional who is able to master the process of project management can achieve crucial results and ensure those results meet team, department, and the organization's strategic objectives.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Best Practices for Auditing Computer System Vendors to Reduce Risk

This Webinar will discuss the importance of applying industry best practices when auditing a hardware, software, or other technology vendor, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Site Preparation Strategy for FDA Inspections

Preparing for an FDA inspection is not as daunting as it may seem. Ensuring that your company is in a continuous state of control is the key to having a successful result with minimal findings and / or observations. The discussion will focus on pre-inspection preparation and readiness, tips during an FDA visit and post-inspection analysis and resolution. Further emphasis on personnel training and how to create a successful "back room" is presented.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

3D Printing for Manufacturing Regulated Products - FDA Current Acceptance and Future Projections

3D printing offers the promise of easy and convenient custom manufacture of a variety of products. There have been several developments in the use of this technology to manufacture medical devices and even attempts to manufacture biologics and drugs. However, there is no clear direction from FDA regarding the approvability of products manufactured using 3D printing technology. There are some precedent regulatory paradigms available to understand what FDA may consider when regulating 3D printed products.
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The Fundamentals of Cross-Selling

Learn the importance of cross-selling additional products and services to customers and why it is the most cost-effective way to grow revenue.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Food Labelling: A Practical Guide for Unambiguous Labelling Information and Compliance with Regulatory Requirements

The fundamental rule of food and drinks labelling states that labelling must not mislead consumers. This applies to the entire label, encompassing pictures, graphics and text.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)

While there is very little disagreement about the importance of controlling suppliers and contractors, quality problems and compliance issues attributed to supplier/contractor failures continue to be very problematic in our industry.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

FDA Guidance on Applying Human Factors and Usability Engineering

"Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design" was published by the FDA on June 11, 2011. The webinar will introduce you to the processes covered in that guidance, and how those processes apply to developing medical devices that are safer and meet FDA's latest expectations. This FDA guidance has stepped up expectations for systematic analysis of the hazards associated with the user-device interface. The FDA has stated: "To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used."
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to create an export compliance program under the Export Administration Regulations(EARs)

The US government regulates the export of information, commodities, technology, and software considered important to US in the interests of national security, economic competition, and foreign policy. Since the events of 9/11, US government enforcement has increased due to concerns about terrorism.Exporters need a customized, integrated export compliance program in order to manage their export decisions and to be compliant with the EARs. Penalties for violationof EAR are severe, including fines that can be as high as $250,000 per civil violation and $1,000,000 for criminal violations, as well as 20 years imprisonment per violation.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Medical Device Reporting (MDR)

Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Dealing with the IRS and Other Government Agencies

This webinar discusses the skills and knowledge necessary to be able to communicate effectively with the IRS and other government entities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Detecting and Preventing Procure-to-Pay Fraud

A "How-to" presentation on detecting and preventing fraud in Procurement, Receiving and Disbursements (AP)
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Effective feedback to gain employee cooperation instead of defensiveness

Many supervisors and managers delay in giving employees feedback because they don't know how to successfully resolve defensiveness and other negative reactions, including blame, excuses, and complaints. This allows unproductive employee work behaviors such as spreading negative gossip, surfing the internet instead of working, arriving for work late, or not following procedures to continue and worsen. These unproductive work behaviors cost the organizations hundreds of hours and thousands of dollars, while creating much frustration and stress.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Common Mistakes Made by Employers in OSHA Injury and Illness Recordkeeping

Employers having more than 10 employees and whose organizations are not categorized as a partially exempt industry, must keep a record of the work-related illness and injuries and using OSHA Forms 300, 300A and 301. This webinar will focus on the common mistakes that employers make in determining whether an injury or illness is work-related or recordable on the OSHA 300 Log. Accurate OSHA recordkeeping is important not only in preparing for an OSHA inspection, but also for companies that seek to measure the effectiveness of their safety programs and ensure consistency among an employer's multiple sites in how to record cases.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Emerging Issues in Food Safety

The complexity of defining safe food and examines the factors that impact on microbiological food safety. We will look at the changing nature of foodborne/food transmitted pathogens and the influence of demographics and geography on the changing landscape. The webinar will also discuss roles and responsibilities for mitigating food contamination and foodborne illness.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

ISO 13485 and Regulatory Affairs Training

The Webinar will extensively cover comparison of various QMS Objectives, Objective of ISO 13485:2003, how to set out requirements for a QMS that is capable of consistently meeting customer requirements, including regulatory requirements. The speaker will also speak about the objectives of ISO 9001:2008 and how to set our requirements for a voluntary, generic QMS that is capable of meetings customer & Regulatory requirements, and enhancing customer satisfaction through processes including continual improvement. The webinar will also enhance your knowledge on objective of the FDA Quality System Regulation and how to set our requirements for a QMS that is capable of consistently providing safe and effective medical devices.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

HIPAA Update- The Auditors are Coming and What you Need to do now

The Webinar will discuss the latest HIPAA regulations affecting employer-sponsored group health plans. The Health Insurance Portability and Accountability Act (HIPAA) required the Department of Health and Human Services (HHS) to develop standards for protecting the security of electronic personal health records.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

The federal Anti-Kickback Statute ("AKS") prohibits the offer or payment, as well as the solicitation or receipt, of "any remuneration (including any kickbacks, bribe, or rebate)" in exchange for referrals. The prohibited activity is a two way street, with both the payer and the receiver equally culpable. What constitutes "any remuneration," however, is a gray area. While the statute provides that remuneration includes "any kickback, bribe or rebate," it does not define these terms. Further, there is a prohibition against remuneration "directly or indirectly, overtly or covertly, in cash or in kind."
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Food Safety Standards and the GFSI

The GFSI (Global Food Safety Initiative), which was launched in May 2000. GFSI is being managed by the Consumer Goods Forum. The main objective of this initiative is to "provide continuous improvement in food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide". The GFSI do so with the application of a Guidance Document which covers three main sections: Part I - The Benchmarking Process, Part II - Requirements for the Management of Schemes, Part III - Scheme Scope and Key Elements GFSI. GFSI has already recognized many Food Safety schemes, but the question is which one fits your organization?
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Accounts Payable Payment (ACH, Check, and Card) Fraud, Risk and Risk Mitigation

During this webinar I will highlight several types of payment fraud that occur in today’s business environment. Regardless of your preferred payment method there is the potential for fraud as well as options to eliminate some of the risk.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Introduction to Nanomaterials - Identifying and Managing Health, Safety and Environmental Risks

In general physics' terms, a nanomaterial is any material that has an average particle size of 1 - 100 nanometers (nm), both naturally occurring and manmade. Engineered nanomaterials (ENMs) have been deliberately synthesized or manufactured to have at least one external dimension in the nanoscale, and exhibit resultant unique properties. This webinar will focus on ENMs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Seven Opportunities of Quality by Design (QbD)

This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.
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Best Practices & Procedures 100 percent OSHA Compliance

The best methodology to maintain & improve a safe & motivated working environment is to devise a plan to fulfill its safety and health policy as set out in the Safety Statement. For delivering this policy an effective management structure and arrangements should be put in place. Safety and health objectives and targets should be assigned to all managers and employees. From an organizational management angle, wellbeing is a major factor in quality, productivity, performance and therefore business effectiveness and profit. Rectify any violations that have been noticed during a formal OSHA inspection of your workplace as quickly as possible. The amount of the fine for each OSHA violation can increase exponentially if it is not corrected within the specified time period. Audit the safety and health of your workplace using the resources offered by OSHA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

GAMP 5 and its Application to Computer System Categorization and Validation

We will discuss the importance of categorizing computerized systems used in the manufacture, testing and/or distribution of pharmaceutical, biological or medical device products in accordance with GAMP 5 standards. Classification of the system is key to determining the best strategy and requirements for validating the system and preparing the necessary supporting documentation.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Launching Your Business in the First State- Why You Should Consider Organizing Your Business in Delaware

Most people have heard that Delaware is a popular state in which to organize a new company, but few people know why Delaware is advantageous. Large, publicly held companies may, among other things, choose Delaware because its corporate law is sophisticated and not biased against businesses. However, there are numerous other reasons for choosing Delaware as home for your company. This program will introduce you to the numerous advantages of organizing your company in the First State.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

FSMA - New requirements to export food products to the US

The FSMA (Food Safety Modernization Act) was signed into law by President Obama on January 4, 2011. The FSMA is divided into four titles: prevention of food safety hazards, improving the safety of imported foods, detection of and response to food safety problems, and miscellaneous provisions. This new law establishes new responsibilities for companies that export products to the US along with other provisions for local companies. There are four main provisions for imported goods:
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Competitive Intelligence Compliance Issues

This course will deal with proven techniques for controlling a business' exposure to the ordinary risks associated with competitive intelligence (CI) activities. Competitive intelligence (CI) has become a major input to a wide variety of executive and management decisions, ranging from strategy to marketing, and from product development to production. Over time, the number of people involved in doing CI research and analysis has expanded, both inside and outside businesses.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Clinical Trial Monitoring - GCP Expectations

This course clarifies the role of the Clinical Research Monitor and explains their responsibilities under the FDA-ICH GCP guidelines. This course will also discuss interactions with others in key roles as part of the clinical trial as well as exploring some aspects of clinical trial monitoring.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Quality Writing for Technical Communicators

Technical disciplines require extensive writing to a broad range of audiences, from fellow subject-matter experts concerned with methodology and processes to non-expert decision makers who are interested in cost-benefit analyses and organizational impact. The science intensive focus of technical disciplines leaves little time for this key segment of the business population to focus on quality writing. But this fact does not change the hard reality that technical communicators spend much of their time drafting and presenting analyses, findings, and recommendations. It is a myth that they don’t need to write well, as effective writing will directly affect their influence within the company.
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FDA Approval of Adaptive Clinical Trials: Practical Tips to Maximize Benefits from Smart Trial Design

Mid-way during an ongoing clinical trial, critical information may be anticipated, that could potentially influence the outcome of the entire trial. The trial may benefit enormously if it can be modified to address mid-study new information. A clinical trial design that allows such a modification is called an Adaptive Clinical Trial. Adaptive trials could allow for significant reduction in the cost and time to market for the products under development, and can also increase the probability of success of the development program. Such trials can be employed for all kinds of FDA-regulated products. This seminar will discuss key statistical and regulatory strategies for adaptive clinical trials based of guidance from FDA and case studies.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Preparing for an FDA API GMP Inspection

Over the past 2 years, FDA inspections of API sites have uncovered significant violations and resulted in major regulatory action. FDA Inspectors continue to observe an increasing level of deficiencies at these facilities. This trend is troubling and createsoperating and business problems for both the API industry and the consumers of their products - Drug Product manufacturers. Even more important is the potential risk to human and animal health that may exist due to these GMP violations!
Recorded Session Access recorded sessions unlimited viewing for 6 months. $299.00

California Wage and Hour Law Compliance: Payroll Unique to the Golden State

This 90 minute California Wage and Hour Compliance training will help you understand the complexities surrounding California Wage and Hour Law Compliance and how it affects the function of any payroll department or company that has employees in California.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

System Safety Principles and Practices

Mil-Std-882 is the primary standard for teaching system safety engineering and management. NASA and all DoD contractors are required to include this standard in the contracts.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

OSHA Refresher Course: Fall Protection

Outline of primary risks and challenges present during operations that your staff and contracted personnel confront when working at heights from four (4) to six (6) feet above its surroundings and lower level. The standard sets uniform threshold heights of four (4) feet for General Industry and six (6) feet for Construction per OSHA Regulations contained in 29 CFR 1910 & 1926.
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Nonresident Alien Vendors - How to Handle the Information Reporting and Backup Withholding Requirements

How can you tell your vendor or payee is a nonresident alien? What if you send them a 1099 when you should have sent them a 1042-S with backup withholding for the payments you made to them? How will you deal with the IRS demand for the backup withholding you failed to deduct from the NRAs payments? In just 90 minutes, you can develop a solid plan to move your company toward near absolute regulatory compliance, efficiency improvements, standardized processes, & adequate documentation to ensure your nonresident alien payments are properly handled according to IRS and tax treaty regulations. You will learn how to obtain the treaties and confirm exemption claims made by your NRA's.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Best safe work practices for controlling risks for confined space - hot work - welding

Safe work practices (SWP) is a process to identify, assess, and mitigate, control or eliminate the risks associated with work. Safe work practices (SWP) in an organization will provide a systematic process to ensure that all safety considerations and precautions are in place prior to starting the job. It is the employer’s responsibility to ensure that all employees are well trained and well informed of the work procedures.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Generation of Controlled Documents and Related Training

This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Fundamentals of environmental impact assessment

This course will discuss:
Recorded Session Access recorded sessions unlimited viewing for 6 months. $193.00

Principles of Green Chemistry

The U.S. Environmental Protection Agency (EPA) defines Green Chemistry as "the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances. Green chemistry applies across the life cycle of a chemical product, including its design, manufacture, and use".
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

TRAIN THE TRAINER - How To Create Change In Your Audience

The very first thing that you have to do if you want to be a great trainer is to instigate change in your audience. They should go out and take actions on your message and implement your advice. This program aims to train you on the tools and techniques for an effective delivery of training sessions and to be an exceptional trainer. There will be a good experience via both theoretical and practical means on learning new skills and ideas. After this webinar you will be able to design, deliver and evaluate training and will also gain an understanding of how people learn and how to deliver a change oriented training program. The webinar is inspired by a great quote from Benjamin Franklin:
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To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial

Risk management is the operative system in the pharmaceutical product development process. GCP Non Compliance at the investigator site remains the sponsor’s primary liability for the rejection of the regulatory application. Fifty percent of all FDA study related investigational site inspections incur some level of GCP noncompliance observations.
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Navigating Today's Business Challenges Through Pro-Active Internal Auditing

Business challenges in today's economy range from ongoing legislative issues to competitive business environments and climates. Internal Audit must be constantly aware of changing facets that may impact operations of their companies. The challenges are vas and the opportunities are great. Many methods exist for auditors to advance their skill sets in today's business. The key is, how, when and where should your efforts be focused.
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Understanding International ACH

Learn about another method for making international payments which are cost effective and secure. There are many ways of making payments internationally. International ACH is one that is often not understood but can be very advantageous for efficiently and cost-effectively making payments to other countries.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

FDA Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices

This webinar introduces FDA’s guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" that was published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Supplier Quality Agreements – Essential for Suppliers of many outsourced processes

Detailed supplier QA agreements with key suppliers, whether standalone or part of a larger supplier agreement, are becoming essential as more medical device companies are looking to increase their outsourcing.
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Design Control for Professionals

Since 1984 the FDA has identified the lack of proper design controls as one of the major reasons for device recalls. This was the reason FDA formalized the legal requirement for design controls in the Medical Device Amendments of 1996. Device experts have estimated it cost 10 times more resources to correct a poor design after it has been in manufacture than to design it right to begin with. This is in addition to the bad publicity of recalls and other regulatory action. This webinar will emphasize key portions of good design control and poor design control along with some important tools learned by the author over the last 25 years.
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HR Metrics: Critical Issues in Measuring Human Resources

The purposes of an organization’s human resources are to add value, make the organization more competitive, and help the organization achieve its business objectives. The purpose of HR metrics is to help communicate the value added, demonstrate the contribution of human capital, and measure employment related risks.
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Update: Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea

This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.
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Understanding the European Union (EU) 'REACH' Regulation : the Registration, Evaluation, Authorization, and Restriction of Chemicals

REACH is a complex, far-ranging, and rigorous law regulating chemicals and impacting chemical-containing products and/or parts that may/may not have Material/Safety Data Sheets (M/SDSs). Promulgated on December 18, 2006, REACH went into full force on June 1, 2007 and will be phased-in over 10 years.
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Understanding ISO 14971:2012: Changes to Annex Z and Impact on the Risk Management File

ISO 14971 has long been the gold standard of risk management for medical device companies. Recently, several changes to Annex Z have been implemented in the 2012 revision which otherwise may go unnoticed but which have significant impact to the risk management file.
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Compensation: Exempt & Non-Exempt

The Fair Labor Standards Act (FLSA) establishes minimum wage, overtime pay, recordkeeping, and youth employment standards affecting employees in the private sector and in Federal, State, and local governments.
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Retaliation in Workplace Investigations - Not If - But When, How and From Whom It Will Occur

Every company will inevitably encounter times when they must conduct internal investigations of employee conduct. One of the most important and often overlooked parts of a professional investigation is the obligation to protect involved parties, not just complainants but also witnesses, and other stakeholder parties against retaliation.
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Description of roles of participants to a clinical trial

Who takes part in clinical research and what does each of participants. Several persons have a role in the management of a clinical trial/observational study and each role has own characteristics that make it unique. For a good result of the study it's crucial that anyone is aware of own obligations and how to carry out them.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $193.00

Health Care Reform Compliance: Avoiding Penalties

This course will review the multitude of requirements under health care reform for employers that sponsor health plans. Under health care reform, employers that sponsor health plans have to follow numerous rules related to plan design, eligibility, notices, payment of fees, etc.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Reducing Risk through Computer Vendor Audits

We will discuss the importance of applying industry best practices for reducing risk by conducting a thorough vendor audit of vendors producing hardware, software and other computerized components that are purchased and used by a company that is regulated by FDA. These systems and components must meet all requirements for computer system validation, as prescribed by FDA. As such, the vendor must assure that all of their processes for manufacturing and testing the systems and components will also meet FDA's criteria.
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FDA vs EU Inspections – Getting Prepared and What are Differences

This training is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

The Impact of The National Labor Relations Act on Your At-will Policies, Social media Policies and Confidentiality Agreements

The Webinar will discuss the impact that decisions by the National Labor Relations Board are having on non-union companies and how they word their policies regarding confidentiality, at-will status and social media. With a full National Labor Relations Board for the first time in ten years decisions will be made that will affect companies in 2014.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Best Practices for Documenting a Computer System Validation Process

We will discuss the importance of applying industry best practices when documenting the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
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How to Protect Your Intellectual Property Abroad

This training will review a number of actions exporters should take to protect their patents (inventions), trademarks (words and symbols that identify products) and copyrights (works of art or authorship) in foreign markets.
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CAPA Training and Causes of Warning Letters due to Lack of Comprehension

A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system.
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So You Have a Potential Whistleblower Suit: Where Do You Go From Here

The program will provide an overview of the Federal Civil False Claims Act (FCA), including how to determine if you have a viable whistleblower suit. We will discuss what type of evidence you need to have to proceed with the suit. The program will take the FCA and show step by step how an action is filed, how the government responds and how the courts interpret various elements of the FCA. We will discuss proof, damages under the FCA and how a whistleblower is rewarded for bringing a successful case. Retaliation will be discussed, along with and how the whistleblower is protected from retaliation under the FCA.
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Tax Levies and Creditor Garnishments: What Payroll Must Know to Stay in Compliance

This 90 minute webinar concentrates on processing garnishments in the payroll department other than child support. It covers the federal rules for creditor garnishments, the IRS rules for federal tax levies, the various aspects of state tax levies, the key points for processing state creditor garnishments, student loans and how to handle voluntary wage assignments such as payday loans.
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Quality System Regulation, Subpart G: Production and Process Controls

The Quality System Regulation (QSR) Subpart G defines the requirements for Production and Process Controls. The FDA's Quality System Inspection Technique (QSIT) inspectional methodology "divides" the requirements for medical device manufacturers into seven subsystems; two of those are the Production and Process Controls subsystem and the Equipment and Facilities Controls subsystem, both of which are contained in 21 CFR 820 (Subpart G).
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Integrating ISO 14971 Risk Analysis Into the Product Development Process

This seminar will present a best practice for integrating risk analysis into a Quality System. That integrated risk analysis process creates a closed loop system that identifies risks, defines downstream risk based requirements and analyzes feedback from downstream process to adjust hazards, risk levels and requirements. The integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to verify risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.
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Creating a Culture of Health

To be most effective, wellness programs must become fully ingrained in the culture of an organization. In fact, research shows that companies with a strong culture of health have 3 times the participation rates in their programs.
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Strategies for Preserving Records with Long Retention Times

The creation of critical information is now mostly being performed by utilizing commercially available software. Computer hardware as well as software continues to evolve and change rapidly. Many files that were created as little as 10 years ago are not easily viewed with contemporary hardware and software.
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Designing and Using KPIs and Performance Dashboards

Designing, developing and supporting an effective reporting system of leading and lagging KPIs (Key Performance Indicators) is complicated. Information needed by senior management is different and less granular than that needed by the line manager, and the producers. The technical aspects of pulling the right information from the mountains of data at the right time can be overwhelming. We can help demystify this puzzle and put your team on the track to smooth sailing. Join us and accelerate your team's understanding and effectiveness in designing, implementing and monitoring critical KPIs using powerful performance dashboards. Learn how to tailor your dashboards to perfectly fit the needs of your C-suite, middle managers, and line and field personnel.
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Mapping the ICH Q10 Quality System to ICH Q7A, Active Pharmaceutical Ingredients GMP and Part 210-211, Final Dosage GMP

The FDA and other regulatory bodies have attempted to define quality activities, roles, and responsibilities since regulation began. As you know, compliance describes the minimum level of quality required to maintain a state of control. Compliance has focused on documentation of quality activities and less on user/patient needs and requirements. Granted, regulation is needed to help overcome the inertia of human behavior.
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Medical Foods:Practical Tips to Meet FDA Requirements for Claims and Quality

Medical foods play an important role in the management of patients with special dietary restrictions and needs. The designation of medical food by FDA implies special handling, labeling, distribution and manufacturing requirements. Manufacturers are usually worried about meeting all of FDA's complex requirements for such products. This seminar will discuss the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be discussed.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Safe Drinking Water-Another Oxymoron?

This webinar will look at the historical use of indicator organisms to define the safety of drinking water and will examine the limitations of this approach for evaluating water potability. Waterborne outbreaks will be reviewed in the context of identifying the wide etiological scope and the inability of traditional indicators to mitigate these risks. Alternate considerations for assessing potability will also be discussed.
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Raising the Bar- The Secrets of Motivating, Coaching and Engaging Employees

Often what a manager says to an employee one-on-one can make or break that employee's performance. Good managers don't wait for mistakes; they provide regular motivation and coaching to help employees avoid them. In this program, Judi shows you how to become a great motivator & coach. You'll learn how to develop the communication skills you need to relate to your employees in a way that will encourage each of them to work better, smarter, & harder. With these tools, your employees will reach a new level of employee engagement and tap into their zones of creativity and high productivity.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Child Support: What Payroll Doesn’t Know Can Hurt You

This webinar focuses on child support garnishments and includes best practices for processing child support in a payroll department. The webinar includes the rules and regulations governing child support as well as calculation examples.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Examining and Detecting Digital Fraud

Today's difficult economic environment contributes to an increased risk of corporate fraud. Advancements in technology have created numerous risks that today's professionals should be aware of when evaluating scenarios for potential fraud. Although the digital age has definitely enriched out lives, it has done so for the crooks as well. Networking of data, digitalization and social networking has created an environment that is cheaper, faster and easier to exploit with illegal activities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements

In the last 4 years the number of FDA warning letter to manufactures of dietary supplement manufacturers have seen a significant increase. Since the implementation of the GMP regulation of dietary supplements in 2007, FDA has conducted numerous audits of manufacturers and suppliers of these products and taken several enforcement actions against products of sub-standard quality, adulterated, false-advertised, or misleading products. To add to that, a vast majority of supplements are imported from manufacturers located in countries with poor GMP requirements for such products.
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Techniques To Avoid OSHA Violations

Best methodologies to maintain a safe & motivated working environment is to avoid OSHA violations by maintaining complete records in compliance with the government standards. OSHA needs you to keep detailed records of all employee accidents or illnesses that may have been occurred due to exposure to hazardous material or unsafe conditions. Always document all the monthly safety meetings that have been conducted in accordance with OSHA standards. Keep a tab on any complaint filed with OSHA with regards to safety and health issues in your workplace.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Creating a Risk-based Supplier Management program

This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while using risk information so you may reduce your cost of compliance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Design for Safety

Designing a system right depends on how early we perform the hazard analysis, which analysis tools we use, and understanding of the system of systems. Most aerospace contractors perform the hazard analysis too late and therefore have to depend on fixing one hazard at a time instead of fixing them before they cause the mishaps.
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Compliance WithThe Insurers' Requirement to Investigate and Defeat Fraud

This webinar provides the training required by California and other states for the annual training of integral anti-fraud personnel. It highlights the recognition of the indicators or red flags of insurance fraud; referral of insurance fraud investigations to the special Fraud Investigation Unit (SIU); and the basic investigation of a potentially fraudulent insurance claim.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $200.00

ISO 13485-an Effective Quality Management System

ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
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Training Requirements under FDA's Quality System Regulation

Training requirements can make or break a firm's compliance program. A weak training program becomes a weak link in a firm's ability to makea product that conforms to FDA requirements.
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Corrective and Preventive Action (CAPA)

Corrective and Preventive Action (CAPA) is a requirement under international standards such as ISO 13485:2003 and FDA under 21CFR 820.
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Understanding and Administering COBRA

The Consolidated Omnibus Budget Reconciliation Act (COBRA) requires employers to allow employees to continue group health care coverage for 18 to 36 months following termination of employment or reduction in hours. Premiums are paid by the employee. However, administration of COBRA is not always as simple as one might expect. For example, family members of an employee are entitled to certain COBRA benefits. Some employees enjoy benefits for 18 months while others are entitled to 36 months of benefits. Now with a number of states recognizing same sex marriage, gay employees may cover spouses under COBRA. This program will provide a clear overview of COBRA with pragmatic advice for administering it in your company.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

21 CFR 820 Best Practice, Requirements Traceability From Source Documents Through Design Validation

This seminar will show you how to effectively integrate requirements tractability into your product development process. This systematic process links all User Needs, Intended Uses, regulatory requirements and functional requirements from source documents through Design Inputs, Design Output, Design Verification and Design Validation.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Crane and Rigging Safety

This course introduces the student to the various types of mobile cranes and tower cranes used in construction operations. Students are provided with intermediate information concerning crane operations, crane inspection and maintenance, rigging inspection, reading load charts, and corresponding OSHA and consensus standards.
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Wellness on a Shoestring

Due to the challenging economy, many companies have cut their wellness program budgets, despite their success in reducing health care costs. These programs, however, can still be effective, even with limited resources. Wellness on a Shoestring is based on the speaker's 40 years of experience in developing inexpensive, but effective, approaches to improving employee/member health.
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The Export Control Reform Initiative: Sweeping Changes and How to Comply

Fundamentals of the Export Control Reform Initiave: Sweeping Changes and What They Mean to You. The Export Control Reform (ECR) initiative of 2013 represents the most sweeping changes in US export regulations in the last 25 years. The initiative is in response to the Obama Administrations goal of doubling U.S. Exports over the next 5 years.
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Traceability System in the Food Chain: Design and Implementation with Special Focus on Food Safety

The escalating and heavily publicized outbreaks of foodborne diseases have raised awareness of the need to ensure food quality and safety. This need drives much of the innovation to trace food consistently and efficiently from the point of origin to the point of consumption (from farm to fork). In addition, regulations, international standards and commercial standards require traceability systems but none is prescriptive in the way traceability is achieved. This is because many options are available. This issue highlight the practical difficulties in designing a traceability system.
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Batch Production Record and Device History Record Review and Quality Assessment

Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution.
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The Evolving Role of the Regulatory Professional

Regulatory professionals don't have an easy job. Initially faced with constraints and roadblocks put in place by organizations, it is almost impossible to perform the job expected by all stakeholders, including regulatory agencies. As the regulatory environment evolves within the organization, the role becomes more palatable, and activities can be accomplished more easily.
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Introduction to Sales and Use Taxation

Sales tax? Use tax? What's the difference? Must I charge tax on my internet sales? Will I owe taxes in more than one state for the same sale? Why is my drop shipper charging me tax? Why did I receive a NEXUS Questionnaire and what if I don't respond to it? I just received a notice that I have to conduct a self-audit and report my findings to the state - is this for real? I need help!
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Preparing for FDA BIMO Inspection and Management

This webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm's preparation and readiness for an FDA BIMO inspection can be done in a more effective, less burdensome, and easily manageable manner at all levels of organization.
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How Create a Value-Added cGMP & ISO 13485 Internal Auditing System

Internal audits are required by both the FDA and ISO 13485. This webinar will cover creating of a Risk-based an internal auditing program for compliance to FDA and ISO 13485 internal auditing requirements.
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Practical Strategies to a successful 505(b)(2) product

A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3 years of market exclusivity available to the approved product.
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Handling Supplemental Pay under the FLSA

Today's wage and hour environment has become one filled with peril for employers who do not understand how to deal with the Fair Labor Standards Act. The US Department of Labor has stepped up its enforcement efforts by adding investigators, forming an alliance with the American Bar Association in order to refer cases and creating a smart phone application that allows your employees to report their time directly to the USDOL. Wage and hour lawsuits are costing employers into the multi-millions of dollars. Most companies have a basic understanding of how to deal with wages, however, often issues arise when dealing with supplemental pay.
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The Federal False Claims Act –the Government’s Enforcement Tool: Is Your Organization at Risk?

Recent cases and/or enforcement actions involving the FCA raise serious concerns regarding compliance issues with hospital, physician practices and other healthcare entities. Recoveries under the FCA are at an all-time high, and the percentage of actions involving healthcare organizations has been increasing at exponential rates.
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Impact of Integration of Laboratory and Business Systems

We will discuss the importance of applying industry best practices when planning, executing and validating the integration of a laboratory system (Laboratory Automation System (LAS), Laboratory Information Management System (LIMS), eNotebook, etc.) with a business system, such as an ERP or similar type of enterprise or supply-chain automation system. These are commonly integrated in manufacturing companies that use large-scale, enterprise-wide solutions for automating the production, testing and distribution processes in pharmaceutical, biotechnology, medical device or other related FDA-governed industries, and rely on data from laboratory systems to feed information about product quality and/or release.
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Are You a Credit Manager Who Understands the Psychology of Sales?

It has often been said that individuals who work in credit and sales at a company should from time to time change places. Only when we have walked in another person's shoes do we begin to understand the problems, challenges, and issues that they face on a regular basis. This webinar will give credit and sales professionals an insight into the psychology of how each views the joys, disappointments, and frustrations of each other's job responsibilities.
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The ICH Q10 Quality Manual

One of, if not the first document requests made by FDA, other regulatory bodies, or an external auditor is the index to the Quality Manual (QM). The Quality Manual Index (QMI) provides a quick overview of not only the organization of the quality system but also the relationships between multi functions. But perhaps, the most important objective of the QM is that it demonstrates that the company does or does not understand basic quality principles and really understands how inter-functional departments communicate and collaborate in decision-making that is so important to satisfying customer needs and requirements.
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Construct and Manage the Technical File and Design Dossier

This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background.
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What AP Needs to Know About Payroll and Vice Versa

This webinar concentrates on how payroll and accounts payable must work together to ensure compliance with taxation and reporting requirements under the Internal Revenue Code for all payments made in accounts payable to employees. It discusses how, by working together all year round and not just at year end, results in optimum efficiency for both departments. It also ensures that both departments are handling the taxation and/or reporting of payments in total compliance with applicable tax laws.
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When the Whistle Blows at Your Company

Whistleblower hotlines are a typical technique utilized by companies to enhance their anti-fraud controls. Yet surveys show that employees often do not trust the hotlines or their intent.
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Legal Issues in Dealing with Employees with Psychiatric Illnesses under the ADA

Webinar discussing when mental illnesses are disabilities under the ADA and what accommodations may be expected. Maybe it's the Internet; however, it seems that we read about an employee with a history of psychiatric illness coming to work one day and injuring/killing many.
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FDA Inspection and Medical Device Design Control

According to the recent FDA enforcement trends (including 2013), inadequate design control is frequently cited in 483s and FDA warning letters.
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Testing Medical Devices for Efficiency and Efficacy

Testing for safety, reliability, and durability are the most meaningful tests for adequacy of product, efficient performance (no down time, no recalls), and for the highest value (gaining more loyal customers). Unfortunately such knowledge is very thin in the literature. This webinar is based on consultant’s 30 years hands on experience with this knowledge.
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New Rules for Compounding Pharmacies: Best Practices for Compliance

The Drug Quality and Security Act (DQSA), signed into law on the 27 Nov 2013, created new rules for the good manufacturing requirements for compounding pharmacies along with registration requirements and safety reporting obligations. These rules bring compounding pharmacies under more vigorous supervision by giving FDA clearer authority to audit such pharmacies while creating a pathway for compounding pharmacies to voluntarily register with the Agency and sign up to be inspected by the FDA under a new category of FDA-regulated facilities called the "Outsourcing Facility".
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Compliance with the Examination Under Oath Requirement of a Property Insurance Policy

This webinar highlights the requirement in every first party property policy of insurance that an insured, if required by the insurer, appear for and testify at examination under oath. The examination under oath provides the insurer with the opportunity to cross-examine the claim presented by the insured.
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The Affordable Care Act and Patient Experience: What you MUST Know to Achieve High Patient Satisfaction Scores for Maximum Reimbursement

Your organization's financial health is tied into patient satisfaction scores! A portion of your governmental reimbursement is directly proportional to your patient satisfaction scores. Underperformers will receive less money. Raise your scores with these practical and easy-to-implement strategies that you can put in place immediately. Also, patient satisfaction scores are now open to the public. Your reputation is on the line and you need to raise your scores — today.
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How to Protect Your Hospital from a Claim for Negligent Credentialing

Of the 28 states that have addressed negligent credentialing claims, 26 have upheld the claims and only two have rejected them. Hospitals, as corporate entities, have the ultimate responsibility for the quality of medical care provided in their facilities.
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Compliance Basics for Group Insurance Programs

This course will introduce attendees to the basic rules sponsors of group insurance programs must follow. Any employer that sponsors a group insurance program must follow certain rules. This course will cover which employers must follow which rules and introduce the attendees to the various rules.
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Travel & Entertainment Reimbursement Fraud Detection & Prevention

Expense reimbursement fraud—encompassing the myriad forms of employee travel and entertainment (T&E) schemes as well as Purchasing Card (P-Card) fraud—costs organizations hundreds of thousands, if not millions of dollars per year.
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Handling Difficult Conversations with Employees2014

Today's workplace carries more challenges than ever before. Managers are called upon to deal with a diverse workforce with diverse challenges. Often communication can break down when managers have to deliver tough news about substandard performance, workplace change, team conflict, or any number of other problems. Many employees enter the workplace with anger management, substance abuse, mental health, and personal issues that overflow into the workplace. In this program, Judi Clements gives you some valuable guidelines for handling difficult interactions with employees, co-workers, and others. You'll learn some effective ways to facilitate dialogue with your employees in a way that lets you maintain control while bringing out the best in each of them
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Form W-4 for 2014: Best Practices and Compliance Requirements

This webinar discusses the 2014 Form W-4 and the IRS’ requirements for completing, processing, submitting and correcting the form.<br/><br/>
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Food Allergen Programs: Management of Allergen Cross-Contamination and Validation of Cleaning Procedures to Ensure Effective Removal

Very small amount of some allergens such as nuts can cause adverse reactions, including potentially fatal anaphylactic shock. Therefore where HACCP/allergen management plans identify cleaning as a prerequisite to ensure adequate removal of allergens, it is important that cleaning procedures can be proven to be effective. This webinar will provide guidance on how to validate cleaning in terms of allergen removal and it is intended for use in all operations.
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Are Electronic Cigarettes a Public Health Threat or Benefit?

In June 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) became law, and amended the Federal Food, Drug and Cosmetic Act to give the Agency authority to regulate the manufacture, labeling, distribution, and marketing of tobacco products in the United States. Specifically, although a “tobacco product” is defined broadly, in pertinent part, as “any product made or derived from tobacco that is intended for human consumption,” the law only provides FDA with authority to regulate, through the its new Center for Tobacco Products (CTP), cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, any “other tobacco products,” such as electronic cigarettes and their components may become subject to regulation if FDA “deems” such products to be subject to the new law.
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E-Payments - Complying to Auditor's Standards

This webinar will dig in to the emerging market of electronic payments, invoicing, and workflow and how that relates to the myriad of requirements from internal and external auditors. For many years Accounts Payable was an area that saw few changes as far as technology is concerned but the last 5+ years has completed changed that. It took some time for the changes to be adopted by not only the companies they are designed for, but the auditors that review these company's records.
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Putting together a Q-Submission and 510(k): Best Practices

This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission.
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Auditing and examining Travel and Entertainment Expenses

Travel and entertainment expenses are often a businessman's best friend but can be management or an auditors worst nightmare if not properly handle. From a corporate perspective expenditures overall T&E expenditures may often be a minimal percentage of earnings. However this process areas inherently provides prime opportunity for unauthorized or inappropriate and lavish expenditures by executives and personnel.
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Dealing with the Disruptive Practitioner and Meeting the JCAHO Guidelines

Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations.
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21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.
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Risk Analysis and HACCP

This webinar will discuss the use of microbiological risk assessment in the development HACCP programs for food production. It will look at how to assess risk, implement critical control points in the production process and provide insight into how the risks can be managed.The webinar will also address the importance of the team approach to HACCP implementation.<br/>
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Leaning In To the Power of A Remote or Mobile Workplace

Not too long ago the thought of working at home seemed laughable. However, today it’s routine although not as routine as many employees believe. Tech companies were some of the first companies to embrace workingremotely. Yet recently, working remotely has begun to face a backlash from some employers while others continue to scale out their remote and mobile (R/M) workforces.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

How to Translate Academic and Discovery Assays into GLP Compliant Assays

This 1-hr virtual seminar will help you deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts. While academic research needs only to be novel, interesting and scientifically sound to be published, there may be gaps in the known information about the assay to allow it to go into production use, either for internal industrial research laboratory efforts, clinical trial usage or even for use as a diagnostic assay. This assay will help you learn what needs to be done to sheperd any given assay from the academic world to the industrial world.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Adverse Event Reporting Compliance; The Key to Safe Drug Development / Subject Safety

The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Determining a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product

Over-the-counter (OTC) drug products are sold directly to consumers without the need of a prescription from a healthcare provider. In the US, these products are regulated by the Food and Drug Administration (FDA). Because of the large number of marketed OTC drug products, FDA reviews the active ingredients and labeling of over 80 therapeutic classes of drugs (e.g., analgesics) instead of individual drug products. This webinar will provide clarification on determining a regulatory pathway to bring your OTC drug product to market.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Approaches to Improve Regulatory Information Policies and Procedures

Gathering and maintaining records to support submissions to government regulatory organizations for marketing approval and clinical trials support can consume a lot of resources. Since most records are now created electronically, the role of the records room clerk has been largely replaced by specialized software.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened ccontrolled "paper" documents.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

The Credit Risk Management System and Credit Industry Groups

Every company that aims to operate successfully, can only do so when they have a handle on understanding the creditworthiness of their customers. The word "credit" comes from the Latin, "credere", which means to trust. When our customers are "creditworthy" we can also say they are "trustworthy", and that we trust them to pay our invoices for the products and services that were sold to them in advance of payment. The Credit Risk Management System is every company's road map to establishing and maintaining the credit controls that will in turn support an understanding of our customer's ongoing credit worthiness.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Software Process Verification and Validation

The FDA's analysis of 3140 medical device recalls reveals that 7.7% of them are attributable to software failures. Of those software related recalls, 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. Software verification and validation practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Paying for Referrals: Risky Behavior

The Medicare/Medicaid Fraud and Abuse Anti?Kickback Statute (the "Statute") is alive, still with us and as viable as ever. The Statute provides that the offer or payment, as well as the solicitation or receipt, of "any remuneration" in exchange for referrals of any good, facility, service, or item for which payment may be made in whole or in part under Medicare/Medicaid is prohibited.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Foreign Bodies in Foods - Available Techniques for Their Prevention, Control and Detection

Foreign bodies are the most obvious evidence of a contaminated product, its presence in foods is among the biggest source of complaint and prosecution in the food industry. To the food processor or manufacturer, foreign body contamination can be costly and may include the cost of a product recall, legal expenses and ultimately, the costs of lost reputation and consumer confidence.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements

This presentation will provide information on how to review your current risk analysis to make sure you fully comply with the requirements for Risk Analysis under EU Directive 93/42/EEC on Medical Devices and the other European Medical Device directives. The stricter interpretations will be expected during ISO 13485 audits and Technical File and Design Dossier document review starting in 2013. You cannot depend that you can meet these requirements just because your current risk analysis meets ISO14971:2007, unless you are fully aware of the implications of ISO14971:2012.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Accounts Payable Fraud: Detection and Prevention Best Practices

Accounts Payable (AP) is the one business function that, in many organizations, is more vulnerable to fraud than any other. That is because all funds that flow out of the organization must first pass through AP. And over time, dishonest insiders and vendors have created newer and craftier methods of stealing from organizations by exploiting control weaknesses in the AP function.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings

US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments’ Report of Private Label Distributors). To transmit files, companies must use the FDA’s Electronic Submission Gateway (ESG). According to FDA, moving from a paper-based format to an electronic system has improved the timeliness and accuracy of submissions. This webinar will provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

The Essentials of Third Party Sick Pay: What Payroll Must Know to Tax and Report Correctly

This webinar discusses the proper taxation and reporting of the fringe benefit known as third party sick pay. It discusses what is and is not third party sick pay, how the taxation is affected by the status of the provider (is or is not the employer’s agent), when this type of payment is taxable and/or reportable and who is responsible for this taxation and reporting.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

How to Develop Quality Systems for New Diagnostic Assays

This 1-hr virtual seminar will help you understand the the necessary steps of develop a quality system for a new diagnostic assay that will comply with Good Laboratory Practices and Good Manufacturing Practices in the United States. The resulting quality system will support the develop of an assay for diagnostic use that can be approved through either the 510(k) process or the Pre-Market Application (PMA) process.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Compliance with the limitations of an Appraisal-Arbitration Provision of a Fire Policy

Appraisal is a form of alternative dispute resolution where the policyholder appoints a an impartial appraiser, the insurer appoints an impartial appraiser and the two appraisers appoint an umpire to resolve the limited issue of the amount of loss. Appraisal can be as informal as the two appraisers meeting an agreeing on the amount of loss to as extensive as a court trial with multiple witnesses called to testify before the appraisers. The appraisers must limit their work to the amount of loss and should never deal with issues of insurance coverage which is the sole province of the court.  <br/><br/>
Recorded Session Access recorded sessions unlimited viewing for 6 months. $200.00

Investigator initiated trials- What are we doing to ensure human subject protection?

Investigators initiated trials are very essential of any research to be translated from bed to bedside. The inception of these research are only done with a scientific interest in a new or existing drug or device, generate new ideas, and mostly involve collaborative research between different departments and also different types of researchers.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

ICH-FDA Good Clinical Practice – Managing Clinical Trials

This course provides an overview of the critical elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to Sponsor Responsibilities and Quality Management of the clinical trial.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Handling Unethical Office Politics and Favoritism, "Fort and Silo" Builders, and Manipulative Disrupters

Businesses have enough problems today without some employees being the best thing that ever happened to their competition. In addition, becoming an "Employer of Choice" is as much what you Don't give to your employees as much as what you Do give to employees. You don't want to give your employees a workplace in which high performers are frustrated, mistreated and can't function at their best.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Complying with the Rules & Regulations Pertaining to Export Finance: OFAC, Anti-Boycott, and the USA PATRIOT Act

U.S. exporters are not only required to understand complex licensing requirements regarding the goods they sell, they must adhere to U.S. sanctions against “enemy” countries (foreign assets control regulations) and refuse to comply with sanctions imposed by other countries (anti-boycott regulations). These two sets of regulations are partially policed by U.S. banks when handling shipping documents and payments and, if a violation is detected, payments must be frozen and the bank must report the exporter to the authorities. Fines, loss of tax credits, and even jail terms may be imposed.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Avoid Devastating Handoff Errors: Improving Transitions of Care

Eighty (80) percent of serious medical errors involve miscommunication between clinicians when responsibility for patients is handed off from one professional to another, according to the Joint Commission. The Joint Commission goes on to state, "Defective handoffs can lead to delays in treatment, inappropriate treatment, and increased length of stay in the hospital and, in extreme cases, serious physical or psychological injury and death."
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Establishing a Medical Device Reporting System Integrated with a UDI System

This webinar is intended to help you get familiar with the Medical Device Reporting (MDR) pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Is it Method Verification or Validation, or Just Semantics?

The Webinar will discuss the distinction between and for method validation and method verification and the requirements of each analytical approach to comply with ISO/IEC Standard 17025:2005 for a microbiology laboratory accreditation.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a certified physician investigator, will go over the regulations in a user friendly way. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”.<br/><br/>
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Changing Payroll Frequencies: How It Can Be Done

This webinar discusses the legal requirements and the best practices that will be needed when an employer is investigating, contemplating, or initiating a change in payroll frequency.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

The Inside Scoop on Credit Insurance, Put Options, and Non-Recourse Factoring

In this uncertain and highly volatile global economy, it's not only your customer that one needs to worry about but your customer's customer as well. With the tsunami and nuclear fall out in Japan, the uprisings in the Middle East and the economic collapse of the Greek government (and perhaps even our own down the road), no company can operate in a vacuum as the ripple effect of global natural, political and economic disasters can seriously impact the ability of even your best clients to remain in a credit worthy condition. This webinar will discuss the credit risk management products that will safeguard your accounts receivables in the event that your customer defaults on payment or goes bankrupt.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

Better Safe Than Sorry: Legal & Effective Behavioral Interviewing

To prepare, conduct, and evaluate behavioral interviews when hiring or promoting employees; to eliminate subjective hiring decisions and increase effectiveness and validity in the selection process while following legal guidelines.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820

This webinar is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection or for those who are subject to ISO 13485 and/or 21 CFR Part 820.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Motivate and Engage Your Employees to Make Lifestyle Changes

It is one thing to know how to alter one’s behavior, but it is an entirely different matter to be motivated to do so. It is felt that employee motivation is the key factor in determining the success or failure of worksite wellness programs and their ability to reduce health care costs and increase productivity. Health professionals have developed many behavioral techniques to help employees make lifestyle changes.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Understanding and Evaluating The Control Environment

Is the day-to-day control environment within an organization different from the concept of corporate governance? External auditors and internal auditors focus signi?cant attention on the effectiveness of an organization’s control environment when conducting reviews. With the release of COSO 2013, companies must re-evaluate their control structures that support their control environment to ensure they are able to adequately attest to sound entity control principles.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Fringe Benefits: Section 132 and Beyond

This webinar discusses the proper taxation, if any for many of the various fringe benefits offered under Internal Revenue Code 132 and beyond. This includes such items as cell phones, prizes and awards, holiday gifts, employee discounts, small (De Minimis) cash and noncash items and employee achievement awards.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Alternatives for Financing Export Sales

Learn how to better negotiate and structure commercial sales into foreign markets in order to simultaneously increase sales, limit risks, and improve cash flow. Examine tools that enable otherwise intolerable transactions by limiting payment and performance risks and tapping funding sources that are specifically designed for export sales. This session explains the motives of the seller, the foreign buyer, and the seller's bank and then compares structures in order that attendees can craft an appropriate structure for each transaction they encounter.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $199.00

FDA 510(k): Trends, Hurdles, Submission and Clearance

This webinar is intended to help you get familiar with the recent FDA 510(k) trends, hurdles, and submission and clearance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Post Approval Risk Management Strategy

We will discuss how Risk Management Files are developed and maintained in accordance with ISO 14971 throughout the product lifecycle.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

ISO 13485 Quality Management System

Organizations wishing to market Medical Devices in Europe must develop Quality Management Systems in accordance with ISO 13485. Such Quality Systems will also be beneficial for organizations seeking to gain marketing permission from the FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Advancing GRC efforts through the evolution of ERM

An effective enterprise risk management (ERM) program identifies and quantifies all risks and establishes formal risk management processes. A robust ERM program will allow companies to mitigate losses and to facilitate critical decision-making by evaluating uncertain events that could positively affect the business. ERM will also help you identify emerging risks more quickly and improve the capabilities of the risk management system to handle them.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

FDA BIMO Inspection: Preparation and Management: Dos and Don'ts

This webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm’s preparation and management for an FDA BIMO inspection can be done in a more effective, meaningful and easily manageable manner at all levels of organizations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Why is Liver Injury (DILI) the Most Frequent Reason for a Drug Being Pulled from the Market

Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1:10,000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. We all know that AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge but some are very rare so the Investigators must be ‘heads-up’. Add to this, the large number of "non-drug liver injuries, which easily confound the issue. To be forewarned is forearmed.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

20 Characteristics of Successful Worksite Wellness Programs

As research on the effectiveness of worksite wellness programs is showing the positive effects for both the employee and organization, it is important to discuss these matters. A Harvard study found that companies who provide worksite wellness programs have an average return on investment of $3.27 to 1 due to reduced health-care costs and a return on investment of $2.73 to 1 due to reduced absenteeism.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Meeting Magic: Facilitation & Planning Skills for Meeting Productivity

How many hours a day do you spend in meetings? How many of those hours are wasted because people go on and on, interrupt one another, haven’t prepared adequately, or just refuse to participate? Study after study has found that over 50 percent of most meeting time is wasted. More than 90 percent of the attendees admit to daydreaming during the meeting, 73 percent busy themselves doing other work, and about 39 percent actually fall asleep!
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Form W-2 for 2014: All You Need to Know

This webinar discusses the 2014 Form W-2 and the IRS’ requirements for completing, processing, submitting and correcting the form.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Incoterms 2010

Incoterms are standard definitions for terms of shipment (like "FOB") developed by the International Chamber of Commerce (ICC) for use in international sales contracts. Correct use of Incoterms goes a long way to providing the legal certainty upon which mutual confidence between business partners must be based. Over the years, the ICC has made many changes and added to the definitions of these shipping terms in contemporary commercial practice.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Supply-Chain Finance

It seems the latest and greatest technique for creating business efficiencies is "supply-chain management." An important component of this is supply-chain finance. So what, exactly, is "supply-chain finance"? Although the term has been applied in a wide range of contexts, it has particular application to structures in which a bank provides financing to the suppliers of a bank customer.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

FDA Premarket Application Pathways for E-Cigarettes and Other New Tobacco Products

FDA has indicated that the premarket application requirements set forth in the Tobacco Control Act will apply to the new tobacco products (including electronic cigarettes, cigars and dissolvable tobacco) that are captured by the Deeming Regulation. Learn about the different premarket pathways, including the Premarket Tobacco Application, the Substantial Equivalence Report and the Minor Modification Exemption.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls requires tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents. This repetition is a major source of inconsistencies and errors.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Key Practices for 2014

This webinar discusses 4 Key Payroll Practices that will be crucial to the department in 2014. These practices will increase efficiency, cut costs, prevent fines and penalties for errors and help the department identify areas to focus on for improvement in 2014 and beyond.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Design Considerations for Pivotal Clinical Investigations for Medical Devices

This webinar introduces FDA’s guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" that was published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data. Following that, it discusses way that are available to a medical device sponsor, for eliminating bias and variance, both in terms of the study design and the requirements for the personnel that will design and run the studies. Finally, it touches on the study protocol and statistical plan and discusses ways to use those to ensure the success of the study.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Compliance with the Requirements for use of a Claims Handling Expert in Insurance Litigation

The claims handling expert is essential to either pursuing or defending a suit claiming breach of the covenant of good faith and fair dealing. The expert called to testify must be qualified to explain to the trier of fact – judge or jury – the custom and practice of the insurance industry and how the insurer either failed to follow the custom and practice or failed to follow the custom and practice.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $200.00

Form 941 for 2014: All You Need to Know

This webinar covers the IRS Form 941 and its accompanying Form Schedule B for 2014. It discusses what is new for the form in 2014 and covers the requirements for completing each form line by line. It includes the filing requirements and tips on reconciling and balancing the two forms. The webinar also covers the forms used to amend the returns.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

The Respectful Workplace: Harassment Prevention & Discipline for Managers

As Human Resource professionals and managers know, the 21st century has ushered in a new period of harassment and bullying challenges in the workplace. The "workplace" itself has changed from a single site to a vast array of locations, off-site offices, internet sites, and international destinations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Overtime: California Style

This webinar discusses the wage and hour requirements for calculating and paying overtime in the golden state.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Compliance Roles – The Keys to Maintaining Independence and Objectivity

Open discussion of the compliance professionals approach and execution of independence and objectivity is often downplayed within the corporate environment. The issue is recognized among those who are in the compliance role, yet the topic borders on the political line within and organizations hierarchy. Professionals often must learn to "face the music" or "play the politics" even though their ethical and moral code tells them something should be changed.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Comparing the Pharmaceutical and Medical Device Lifecycles

This webinar will explain the workings of the product lifecycle for pharmaceuticals and medical devices. Although the goal of product lifecycle is to yield a product meeting user and customer requirements, the product lifecycle differs between pharmaceuticals and medical devices because of the nature the products and their intended use.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Using the ISP98 Model Forms for Standby Letters of Credit

Letters of credit are commonly used in business transactions to ensure payment and performance by the parties. Over $600 billion of standby letters of credit are currently outstanding in the US marketplace. The transactions they support can be complex, leading to concern that the letters of credit be properly worded.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Developing the Quality System from Scratch

The opportunity to design a quality system from scratch offers great rewards in experiencing and understanding the functions of quality systems. For me, this "dream" of building the "perfect quality system" began during my early quality management days as I learned and experienced quality system successes and failures. I learned from these thinking and dreaming, "If only I could set up my own quality system".
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

The 10 Most Common Misconceptions about Payroll and How to Avoid Them

This webinar discusses 10 areas of wage and hour law that when misunderstood or applied incorrectly causes employees to be paid incorrectly with the resulting penalties, fines and interest. Some of these misconceptions can even cause the employer to overpay employees forcing unnecessarily higher labor costs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

FDA Good Laboratory Practice (GLP) Inspection Preparation and Management: Dos and Don’ts

This webinar is intended to help you get familiar with FDA Good Laboratory Practice (GLP) Inspection and Preparation – Dos and Don’ts. We discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don’ts before, during and after the FDA GLP inspection will be discussed.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Managing Foreign Inspections - Before, During and After

The importation of products regulated by FDA has grown steadily and will continue to grow. Manufacturing capacities, international economic growth and new markets drive global commerce and likewise the expansion of imports and exports. Over the past several years, however, problems with foreign manufacturers has become more evident and has prompted Congress and FDA to implement tougher import requirements.
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FDA Rules for Trial Master Files

The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project.
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Compliance with the Obligations of a Public Adjuster

The public insurance adjuster acts for a policyholder to prepare and present a claim to an insurer. The public insurance adjuster obtains a contract from the policyholder who agrees to pay a percentage of the amount recovered from the insurer to the public adjuster.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $200.00

FDA 510(k): Good Practices for 510(k) Preparation and Submission Compliant with eCopy and RTA Policy

This webinar is intended to discuss good practices for premarket notification [510(k)] preparation and submission compliant with eCopy and Refuse to Accept (RTA) Policy requirements.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

21 CFR 11 Compliance for Excel Spreadsheets

FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Off-Label Uses of Medical Products Under FDA Rules: Walking the Fine Line of Promotion Verses Scientific Discussion

FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Multistate Taxation: What Payroll Must Know Now

This 90 minute webinar focuses the best practices and requirements needed to properly deduct and/or pay the state income tax, local taxes, and state unemployment insurance for an employee who lives and works in two separate states or who works in two or more states.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Internal Controls - What Every Manager Needs to Know

This webinar will provide participants with a fresh view of what every manager needs to understand about the concept of internal controls. It will review the practical aspects of internal controls in the operational, compliance and financial reporting areas.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

Preparing For Year-End 2013 and Year Beginning 2014

This 90 minute webinar focuses the best practices and requirements needed to successfully close out the calendar tax year 2013 and to begin the new payroll processing calendar year 2014.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $189.00

Implementing a Unique Device Identification (UDI) system

This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules and adequately implement a UDI system in accordance with the final rules, issued on September 24, 2013.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Good Beginnings Make Good Employees: Legal & Effective New Employee Orientations

From the first day new employees start on the job, they begin to make judgments about the company, their manager, their peers, and the job they’ve been hired to do. Too many first days are wasted days with new employees sitting around doing nothing while they wait for their managers to pay attention to them.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

The Tort of Bad Faith

An introduction to the birth, growth, spread, and use of the tort of bad faith and how it was used to force insurers to deal fairly and in good faith with their insureds.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $200.00

Overview of FDA Regulations for Drugs, Biologics and Medical Devices including IVDs

Have you ever wondered what regulations are applicable for drugs, biologics and medical devices during preclinical, clinical and postmarket phases? This webinar is intended to help you get familiar with the US regulations governing drugs, biologics, and medical devices including in vitro diagnostic medical devices (IVDs).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Fraud Awareness Programs

This training on fraud awareness program will discuss recent history and profile of fraud cases and will help attendees understand specific processes and techniques needed to be effective when providing assistance on fraud issues.
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How to Prepare for an FDA Meeting: FDA meeting basics for drug and biologics companies

Formal meetings with the reviewers of the US Food and Drug Administration (FDA) are perhaps one of the most important and useful resource available to the sponsors of medicinal products looking to get marketing approval in the US.
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Writing Effective SOP’s

Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

3-hr Virtual Seminar: Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)

While there is very little disagreement about the importance of controlling suppliers and contractors, quality problems and compliance issues attributed to supplier/contractor failures continue to be very problematic in our industry.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Why Pharmacovigilance (Phase IV) Trials are Increasingly Seen: Why they are Important and what they tell us?

FDA-mandated post-market studies are here. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy of negotiating post-market commitments with sponsors - and will now set mandatory objectives and timelines.
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The Ethical Dilemma Faced by Fighting Insurance Fraud

The course covers the obligation imposed on insurers by state law to actively investigate and defeat attempts at insurance fraud and the ethical dilemma posed by the covenant of good faith and fair dealing when fraud is suspected. Insurers and their claims and investigative personnel owe their first duty to deal fairly and in good faith with the person insured. If fraud is suspected the insurer must balance the obligation deal fairly and in good faith with the duty to investigate, defeat, and assist the state to prosecute insurance fraud.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $200.00

If It Wasn’t Documented It Didn’t Happen: Legal & Effective Discipline & Documentation

In our litigious society, it has become more & more important for supervisors to know how to document & discipline employees to avoid law suits and manage employee performance effectively. In this program, Judi gives managers a "crash course" in safe, legal, & effective disciplinary practices & documentation.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

10 Steps to Perfect SOPs: FDA Compliance made easy

Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Auditing of Environmental, Health and Safety programs for the non-technical auditor

This training on EH&S compliance will provide you the powerful tools for building successful audit program for environmental health and safety concerns to ensure compliance with EPA and OSHA policies.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $236.00

How to interpret and Use Laboratory Data to protect the Safety of Subjects in Clinical Research Studies

All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Performance Appraisal Toolbox: How to Prepare & Deliver Legal & Effective Appraisals

It's often called the "most dreaded management task". It's the performance appraisal. How do you evaluate your employees' performance without soft peddling the difficult stuff or being hypercritical and risking a defensive reaction? In this program, Judi prepares managers & supervisors for this difficult, yet very important, job.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

California Wage and Hour Law Compliance: Payroll Unique to the Golden State

This 90 minute California Wage and Hour Compliance training will help you understand the complexities surrounding California Wage and Hour Law Compliance and how it affects the function of any payroll department or company that has employees in California.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $239.00

Auditing for 21 CFR Part 11

21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements

In the last 4 years the number of FDA warning letter to manufactures of dietary supplement manufacturers have seen a significant increase. Since the implementation of the GMP regulation of dietary supplements in 2007, FDA has conducted numerous audits of manufacturers and suppliers of these products and taken several enforcement actions against products of sub-standard quality, adulterated, false-advertised, or misleading products.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Preparing for an FDA Audit of your facility

Each year FDA audits more than 16,000 facilities involved in manufacture, testing or development of food and drug products, and collects more than 25,000 product samples for analysis at its labs. These include not only drugs and biologics but also medical devices, diagnostic kits, dietary supplements, veterinary products, and animal and clinical testing facilities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Good Practices for an FDA Inspection Preparation and Readiness: Dos and Don'ts

This webinar is intended to help you get familiar with how to prepare for and get ready for an FDA inspection. This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don'ts before, during and after the inspection will be discussed.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Focus on Internal Control – Is your Company Ready for the New COSO?

This webinar will highlight as well as compare and contrast the critical concepts of two leading compliance documents that are sure to turn up the heat on management’s efforts related to internal control. The COSO foundation will be releasing their 2013 internal control framework in the coming months.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Critical SOPs for Clinical Sites

Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

W-2s vs. 1099s Who Should and Should Not be an Independent Contractor

This 90 minute webinar focuses in on classifying workers as either employees or independent contractors under the IRS and Department of Labor rules and regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

IRB and Other Committees

Many Hospitals and Clinics today are looking for ways to increase revenues. One way is for them to do more clinical trials. In order to do this they must prepare their staffs to be ready to do clinical trials. This is the first in a series of training sessions intended to do that.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Computer System and Software Validation

We will discuss ways Medical Device manufacturers can organize, document and prepare to present their software validation efforts during FDA Investigations or ISO Registrar audits.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Changes in FDA's Device Corrections and Removals Reporting

FDA has proposed a dramatic change to what should be reported under the Corrections and Removals regulation for devices. The change significantly broadens the scope of what is reportable to FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Systems Validation Made Easy

21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, proper documentation is a daunting task.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Records Preservation Strategies that will Assure Authentication

The creation of records is now mostly being performed by utilizing commercially available software. Computer hardware as well as software continues to evolve and change rapidly. Many files that were created as little as 10 years ago are not easily viewed with contemporary hardware and software.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

FDA 510(k) Update: Recent Trends and Good Practices Compliant with eCopy and RTA policy

This webinar is intended to get familiar with the recent 510(k) trends and to help you implement good practices for your successful 510(k) preparation, submission and clearance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea

This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

FDA Rules for using Social Media for Marketing Prescription Products

Social media offers an excellent opportunity for a company to get the word out about its drugs, biologics, medical devices and diagnostic kits. However, FDA regulated products need to follow strict information control; any information distributed to consumers must be approved by FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Current Concepts & Challenges in Cloud Compliance

Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to select Software for a Regulated Environment

Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added challenge of being subject to both regulations that add another degree of complexity to this already complex task.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

FDA Warning Letter Management

A Warning Letter gives you legal notice of possible legal action against you by the FDA. A Warning Letter from the FDA requires a prompt, thorough and realistic response to mitigate further damage to your business. If you do not respond effectively, you face a long and costly task of rehabilitating your FDA regulatory profile with the agency, your customers and your investors. You need to understand how to manage the FDA's Warning Letter to control the possible skyrocketing cost of noncompliance. The FDA warning letter can quickly start to manage you unless you already have in place a plan to manage the Warning Letter. "A stitch in time saves nine."
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

The Hitchhiker's guide to 483s and Warning Letters

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Survive a DEA Inspection Series: The DEA Computation Chart

This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

The Sunshine Act Reporting for Clinical Trials

Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Practical Guide to FDA Inspections

FDA's standard inspectional operations are discussed in the webinar so you can establish or revised your FDA inspection protocol before an inspection occurs. Most FDA inspections follow a standard procedure.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

FDA's New Guideline regarding Contract Manufacturing Arrangements for Drugs: QUALITY AGREEMENTS

This presentation outlines the contents of the FDA's Industry Guidance draft document titled Contract Manufacturing Arrangements for Drugs: Quality Agreements issued in May of 2013. While this was issued as a draft document, we know that while there may be some changes in wording, this Guidance Document is notification of FDA thinking and will be enforced as a cGMP document.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Part 11 Compliance and the Role of Standard Operating Procedures

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, it is important to remember that not only are technical controls but there are procedural controls as well.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Record Retention - Long Enough or Too Long? A practical Guide

Most people have the tendency to save many things that have surpassed their useful life-time. The advent of electronic records has made it easier to save almost everything indefinitely because archives are less visible and storage cost is cheap.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Recent cGMP Violations and How to Avoid Citations

This presentation reveals the recent cGMP citations and discusses what could have been done to prevent them. By learning these two fundamentals and establishing a proactive program of compliance, any pharmaceutical manufacturer can avoid serious cGMP citations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

10 Steps to an FDA-Acceptable Clinical Trial Protocol

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Strategies to Capture, Preserve and Authenticate R&D Information for Patent Protection and Litigation

A fundamental premise in the Pharmaceutical and Biotech business is that you can legally exclude competitors from copying your drug product for a certain period of time. Obtaining patent coverage in the US and other countries can be an expensive and daunting process.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

How To Conduct a Successful Process Validation

This presentation covers a methodology that can be used for any oral product process validation
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Improved Generic Drugs via the 505(b)(2) Regulatory Pathway: FDA Approval Made Easy

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Lyophilization and Stabilization of Proteins, Cells and Viruses

This webinar will cover formulation and process development strategies for stabilizing biologically based pharmaceutical and diagnostic products including proteins, cells, and viruses (live, modified live, attenuated). Understanding the degradation mechanisms and improving stability of these molecules through formulation and processing techniques will be discussed in great detail in addition to covering some of the analytical techniques employed to verify the results.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

510(k): Regulatory and Technical Requirements Compliant with eCopy and RTA Policy

This webinar is intended to discuss the premarket notification [510(k)] requirements compliant with eCopy and Refuse to Accept Policy (RTA) requirements.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Quality Management Systems for Medical Devices and IVDs

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…"
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

FDA Import and Export Requirements

Critical issues will be discussed so you can develop and maintain an effective and efficient import / export business. The topics cover legal requirements and practical business operations. Given the FDA's increased scrutiny of international trade, understanding the following topics is essential.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides basic framework for computer systems used to generate records and data, and used for analysis and presentation.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Materials Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity). Understanding if a crystalline, amorphous, mixed, and or metastable system is present in our products, is critical in developing a sound, stable formulation that can easily be freeze-dried.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

EU Medical Device Directive: Preparing for Conformity Assessment Application for CE Marking of Medical Devices

This webinar is intended to help you get familiar with the European Union (EU) Medical Device Directive (MDD) governing medical devices for CE marking. This webinar is further intended to provide guidance on the regulatory requirements set out in the MDD, which helps ensure that medical devices are safe and effective for their intended use.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

IEC 62304: Medical Device Software Development and Validation

Software is a critical element because it ensures product quality and patient safety. Hence it always draws the attention of regulatory agencies such as the USFDA, EMA, TGA etc. The benefits accruing from devices and processes automated through software have been recognized.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Implementing Medical Device Reporting

This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process

This seminar will cover the freezing, annealing, primary drying and secondary drying steps of a lyophilization process. As each of these steps can affect both the chemical and physical integrity of freeze-dried products, it is important to thoroughly understand the scientific principles behind each step, and how to apply them when developing an optimized lyophilization cycle. Additionally, understanding these principles and how then affect the product allows the development scientist to better troubleshoot failed products and or cycles.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Trial Master File (TMF): FDA Expectations from Sponsors and Sites

The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Writing and Enforcing Effective SOPs

Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done."
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

GMP Quality Principles

We all know that when FDA appears at your door to conduct an inspection, 99% of the time, they want to ascertain if you are in compliance with the requirements stated in 21 CFR 210 & 211 - more commonly known as the Current Good Manufacturing Practice Regulations in Manufacturing, Processing, Packing, or Holding of Drugs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Requirements for Medical Device Developers to Meet the U.S. FDA's Requirements on the 510(k)

This webinar is intended to discuss the requirements for medical device developers to meet the U.S. FDA's requirements on the 510(k).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Establish and Maintain an Effective Supplier Qualification Program

FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

21 CFR Part 11 Complying with: Step by Step

There is an increasing use of computers and electronic data in the pharmaceutical industry. Consequently, management of electronic records and data continues to be a concern of the regulators. CFR 21 Part 11 regulations were enacted in 1997 to address those concerns.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

The Infamous Form FDA 483: How you respond can make or break you

The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $299.00

Project Management for Computer Systems Validation

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

FDA Inspection: Preparation and Management

This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Draft Guidance for Device Industry and FDA - Postmarket Surveillance

This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Bulletproofing your cGXP Documentation from Audit Citations

Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List

Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $249.00

Scale Up and Cycle Transfer for Lyophilization Cycles

This webinar will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. By using a methodical approach and understanding the thermal properties of a product, the scale-up or transfer process can be simplified and result in consistent product being produced in any freeze-dryer.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to withstand an FDA audit of your facility

Learning how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How FDA Inspection Observations are Reviewed for Regulatory Action

The presentation covers the different steps in processing observaions and evidence collected during an inspection for possible regulatory action.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

GMP Vendor Audits

Description of a method to establish and conduct GMP audits of vendor facilities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…" This webinar will address the said current good manufacturing practice requirements to help you stay in conformity with 21 CFR Part 820.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

A Practical Look at the Sarbanes - Oxley (SOX) Act of 2002

The legislation came into force in 2002 and introduced major changes to the regulation of financial practice and corporate governance. Named after Senator Paul Sarbanes and Representative Michael Oxley, who were its main architects, it also set a number of deadlines for compliance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $299.00

Computerized System Validation: Basic Concepts

The comprehensive testing and control of computerized systems if first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy of these systems for daily operations. Short of fire or catastrophic natural disasters, nothing is more disruptive to business continuity than the dreaded phrase, "the system is down".
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Container – Closure Systems for Lyophilized Products

This webinar will cover various container closure systems used for freeze-dried products including vials and stoppers, bulk drying trays, and pre-filled syringes. Various aspects of the types of materials used, the specialized coatings available, and the configuration of the different systems will be discussed in relation to the impact on the products and the lyophilization process.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Designing And Implementing The Quality System From Scratch

The opportunity to establish a new quality system from scratch has three potential results. The most rewarding is a cross-functional systems approach that balances quality activities to achieve product performance requirements and meeting internal and external customer requirements (needs & wants). The least desired outcome is a failed quality system that is so dysfunctional that it threatens the organization’s very existence.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

510(k): Format, Contents and Case Studies

This webinar is intended to demonstrate how to prepare a 510(k) in a manner to facilitate the review and for successful clearance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Internal GMP Audits

This presentation provides a complete system for conducting internal GMP audits. It covers what to do and what not to do in performing internal audits for the purpose of assuring full compliance with the GMP regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency…both efficiency in project management, and avoidance of non-compliance penalties.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Optimized Formulation Development for Lyophilized Products

This webinar will cover the process and benefits of developing an optimized formulation for freeze-dried products to improve the quality and consistency of the product while also reducing the cycle time and associated costs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Best Practices for MDRs, Recalls, Corrections, and Removals

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $299.00

Quality SOPs: Guidelines to developing and writing FDA Compliant Documents

Clearly written, detailed Standard Operating Procedures (SOPs) are one of the key indicators of the caliber of regulatory compliance enforced by an organization. SOP reviews are a high priority with auditors during an inspection. Poor quality, incomplete or non-existent SOPs are frequently a definite cause of a failed inspection.
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Use GAMP to Surefire your CSV Audit

Regulatory agencies have stepped up audits to aggressively enforce computer systems validation (CSV) and CFR 21 Part 11/Annex 11 implementation. A third of recent warning letters have cited improper validation and/or incorrect or deficient implementation. After a walkthrough of regulations for CSV, the presentation will transition to a brief explanation of validation enablers as enumerated in ISPE’s GAMP V guide to include the V-model and ASTM’s E-2500 standards. Finally, the webinar addresses e-Validation and their impact on ensuring that Validation is no longer a costly and risky activity.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

FDA Investigations and Inspections

How FDA conducts investigations and inspections. Learn about the tools and procedures the FDA uses to conduct investigations and inspections from a former retired FDA Office of Regulatory Affairs officer.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Critical SOPs for Clinical Sites

Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

How to Implement a Risk Management Process

Risk management is the set of processes through which management identifies, analyzes, and, where necessary, responds appropriately to risks that might adversely affect realization of the organization's business objectives. The response to risks typically depends on their perceived gravity, and involves controlling, avoiding, accepting or transferring them to a third party.
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Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY!
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Survive a DEA Inspection Series: Controlled Substances and Hospitals

This training will cover several recommendations to improve the hospital's Due Diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Improving 510(k) Submission Quality

This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission (“510(k)”) is made to US FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Best Practices for Purchasing and Supplier Controls in the Medical Device Industry

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Best Practices Compliant with the FDA Regulations for Handling Medical Device Complaints

Medical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints.
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How to Survive a DEA Inspection Series: Due Diligences of a Pharmacy

The public media has been reporting the fraud and abuse of narcotic dispensed for pain. Reports target the legitimacy of prescriptions and pharmacist who fulfill them. Federal and state regulations have placed emphasis on corresponding responsibilities for the pharmacist who fulfills those prescriptions.
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Risk Management for Medical Devices: ISO 14971:2007

The company is required to implement a risk management program as an integral part of its quality system. A robust risk management program identifies and manages hazards throughout the product lifecycle. Once identified, hazards must be eliminated or mitigated to achieve the highest possible level of product safety and effectiveness. The company depends on its risk management program to continuously monitor and evaluate potential hazards associated with its products, and to take appropriate actions designed to lower the probability of harm to stakeholders.
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Writing US FDA-acceptable Clinical Trial Protocols

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $299.00

FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begi n with "I agree".
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Lyophilization Process Development and Cycle Design

This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle to improve the quality and consistency of the product while also reducing the cycle time and associated costs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy

Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $299.00

510(k): How To Navigate Through Hurdles And Get It Cleared

This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Survive a DEA Inspection Series - Law Enforcement and Pain Management

Class participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan. Also they will be familiarized with the necessary documentation that should be noted in the patient chart and step to prevent diversion of the dispensed or prescribed drugs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

IND Submission for a 505(b)(2) Product

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. However, 505(b)(2) products require evidence from clinical trials conducted under an IND in support of the marketing approval application.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

The Role of Lab Data in the Drug Development Process: Adverse Events and Subject Safety

All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

510(k): Submission and Clearance

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Survive a DEA Inspection Series: Pharmacy Records and Security

The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Best Practices and FDA-Compliant Medical Device Reports (MDRs), Recall, Corrections and Removals

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

How to Survive a DEA Inspection Series - For Manufacturers and Distributors

The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Best Practices for Establishing a Compliant Medical Device and Complaint Handling System

All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

How to Survive a DEA Inspection Series: DEA Due Diligence for Manufacturers and Distributors

The training will cover several recommendations to improve the Corporate Due Diligence when narcotic drugs are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

510(k) Submission: Contents and Format for Medical Devices

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

Implementing Design control for Medical Devices and IVDs

Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Employee-Organization Relationship-Effective Employee Management

The Employee-Organization Relationship (EOR) has increasingly become a polestar for researchers in organizational behavior, human resource management, and industrial relations. Even the best organizations periodically make mistakes in dealing with employees. They mess up their opportunity to create effective, successful, positive employee relations. Research shows that employees who are motivated, appreciated, and aligned produce measurably better business results.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $699.00

Quality Management System and Internal Auditing for Devices

Effective quality management systems are identified as a pivotal regulatory factor for allowing medical device manufacturers to market their products around the world. ISO 13485 is a quality management system standard particularly for the medical device industry, which encircles key aspects plus additional industry-specific medical device essentials.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $899.00

ISO 14971: Risk Management for Devices

ISO 14971 is an international risk management standard for medical devices. It is widely recognized as the official standard for medical device risk management. ISO 14971 applies to all medical device manufacturers and all medical devices and should be used to manage risk throughout all stages of the product life-cycle from initial concept right through to final disposal.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $599.00

Extensive Package on "Medical Device Reporting" Tutorials

Medical Device Reporting is the means by which adverse events and malfunctions with medical devices are reported to the FDA. Under the Safe Medical Devices Act of 1990, device manufacturers, importers and user facilities must report known device-related deaths to the FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $699.00

Design Control Guidance and IVDs for Medical Devices

The FDA has identified design control as a focal point in its inspectional approach to compliance. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ensure your design or design changes will meet both defined user needs as well as your defined intended uses.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $499.00