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The Basic Requirements for Developing IQ and OQ Protocols
Current regulatory requirements state the need to prove and document that equipment, systems and utilities are verified to perform their desired functions. This verification and documentation comes in the form of qualification protocols that verify proper installation, adequate support utilities, operation over its entire range, and acceptable performance according to established procedures and operational setpoints.
Live Session Wednesday, April 16, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

Techniques for Slashing DSO (Days Sales Outstanding)
Much ado is made of cash management and collection techniques for trimming a few days off of company DSO. In many companies, it is important enough that bonuses are based on shortening DSO. In this session, participants will learn about trade finance techniquesfor negotiating and structuringcompany sales in that allow a company to simultaneously increase sales, limit risks, improve cash flow, and slash DSO, potentially to zero.
Live Session Thursday, April 17, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
Live Session Thursday, April 17, 2014 11:00 AM PDT | 02:00 PM EDT, Duration:60 $199.00

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.
Live Session Thursday, April 17, 2014 10:30 AM PDT | 01:30 PM EDT, Duration:60 $199.00

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.
Live Session Monday, April 21, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Tuesday, April 22, 2014 12:00 PM PDT | 03:00 PM EDT, Duration:90 $199.00

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.
Live Session Tuesday, April 22, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Tuesday, April 22, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Wednesday, April 23, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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.
Live Session Wednesday, April 23, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
Live Session Wednesday, April 23, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Wednesday, April 23, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:60 $143.00

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/>
Live Session Thursday, April 24, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Monday, April 28, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Monday, April 28, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

Chemotherapy a Historical Review
The discovery that certain toxic chemicals administered in combination can cure certain cancers ranks as one of the greatest in modern medicine. Childhood ALL, testicular cancer, and Hodgkin's disease, previously universally fatal, are now generally curable diseases.
Live Session Tuesday, April 29, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $199.00

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.
Live Session Tuesday, April 29, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

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.
Live Session Tuesday, April 29, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
Live Session Tuesday, April 29, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Wednesday, April 30, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:60 $199.00

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.
Live Session Wednesday, April 30, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Wednesday, April 30, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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/>
Live Session Wednesday, April 30, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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
Live Session Thursday, May 1, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $143.00

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.
Live Session Thursday, May 1, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
Live Session Thursday, May 1, 2014 11:00 AM PDT | 02:00 PM EDT, Duration:60 $199.00

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.
Live Session Friday, May 2, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

Quality system requirements for cleaning, maintenance and calibration programs
This webinar is of importance to industry since the programs listed are some of the basic GMP expectations and found in many regulatory requirements. As a regulatory requirement, preventative maintenance, calibration and cleaning programs are what help assure that the validated state of equipment, utilities and systems remain in a state of control.
Live Session Tuesday, May 6, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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.
Live Session Tuesday, May 6, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

Best Practices & Procedures 100 percent OSHA Compliance
Best Methodologies to Maintain & Improve a Safe & Motivated Working Environment.
Live Session Tuesday, May 6, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Wednesday, May 7, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $149.00

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.
Live Session Wednesday, May 7, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $150.00

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".
Live Session Wednesday, May 7, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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.
Live Session Thursday, May 8, 2014 11:00 AM PDT | 02:00 PM EDT, Duration:60 $199.00

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.
Live Session Friday, May 9, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Monday, May 12, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Tuesday, May 13, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $143.00

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.
Live Session Wednesday, May 14, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
Live Session Wednesday, May 14, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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.
Live Session Wednesday, May 14, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $199.00

Bladder and Prostate Cancer a Pathophysiological Review
A Bladder or Prostate Cancer diagnosis is life changing for a patient. As a research professional assigned to oncology trials in any solid organ it is advantageous to have and intermediate understanding of the pathophysiology of the disease process.
Live Session Wednesday, May 14, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
Live Session Wednesday, May 14, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Wednesday, May 14, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $143.00

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.
Live Session Thursday, May 15, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
Live Session Thursday, May 15, 2014 11:00 AM PDT | 02:00 PM EDT, Duration:90 $199.00

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.
Live Session Thursday, May 15, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Thursday, May 15, 2014 11:30 AM PDT | 02:30 PM EDT, Duration:90 $243.00

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.
Live Session Wednesday, May 21, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Tuesday, May 27, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $159.00

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.
Live Session Tuesday, May 27, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Wednesday, May 28, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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!
Live Session Wednesday, May 28, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

Microbial Food Security Risk Analysis
This webinar will discuss the potential threats of using food as biological weapon and the actions food companies can take to mitigate and minimize the risks of food bioterrorism.
Live Session Thursday, May 29, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Thursday, May 29, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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.
Live Session Tuesday, June 3, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $150.00

Preparing for FDA GLP Inspection and Management: 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.
Live Session Wednesday, June 4, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Wednesday, June 4, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

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.
Live Session Thursday, June 5, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

Child Support: What Payroll Doesn’t Know Can Hurt You
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.
Live Session Thursday, June 5, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

Patient Safety Principles and Practices
At least 300 medical errors a day happen in large hospitals. Nearly half the patients can experience a medical error during a 3-4 days stay. It is a crisis in quality care. There has been no progress for the last 10 years. Insurance companies are beginning to outsource medical care overseas because the cost is only one tenth. The Joint Commission is exerting pressure on hospital to improve.
Live Session Thursday, June 5, 2014 11:00 AM PDT | 02:00 PM EDT, Duration:90 $199.00

Techniques To Avoid OSHA Violations
Best Methodologies to Maintain & improve a Safe & Motivated Working Environment & Prevention of OSHA Violations.
Live Session Friday, June 6, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Tuesday, June 10, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Tuesday, June 10, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Wednesday, June 11, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00

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.
Live Session Wednesday, June 18, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00

How to Improve Service Levels in Startup, Small, Medium Sized Businesses with no Capital Investment
Best Methodologies to Improve Service Levels, Reduce Cost, Improve Productivity, Increase Sales & Improve Morale with Zero Capital Investment.
Live Session Tuesday, June 24, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 $199.00

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.
Live Session Tuesday, July 29, 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 10:00 AM PDT | 01:00 PM EDT, Duration:90 $199.00

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.
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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.
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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/>
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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."
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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.
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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/>
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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".
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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.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

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.
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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.
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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.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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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.
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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.
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Electronic Records & Electronic Signatures; 21 CFR Part 11

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.
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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.
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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."
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How To Conduct a Successful Process Validation

This presentation covers a methodology that can be used for any oral product process validation
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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.
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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.
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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.
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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…"
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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.
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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.
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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.
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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.
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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.
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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."
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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.
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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).
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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. $288.00

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.
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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.
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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!
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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.
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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.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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 USFDA-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. $150.00

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. $150.00

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.
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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.
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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.
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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