Recorded Compliance Training, Pharmaceutical Webinars

Establish and Maintain an Effective Supplier Qualification Program

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

21 CFR Part 11 Complying with: Step by Step

Instructor: Chinmoy Roy

There is an increasing use of computers and electronic data in the pharmaceutical industry. Consequently, management of electronic records and data continues to be a concern of the regulators. CFR 21 Part 11 regulations were enacted in 1997 to address those concerns.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

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

Instructor: Casper E Uldriks

The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

The Sunshine Act Reporting for Clinical Trials

Instructor: Mukesh Kumar

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

Project Management for Computer Systems Validation

Instructor: Angela Bazigos

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00

FDA Inspection: Preparation and Management

Instructor: David Lim

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. $150.00

Draft Guidance for Device Industry and FDA - Postmarket Surveillance

Instructor: David R Dills

This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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

Instructor: Jeff Schwegman

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. $150.00

Bulletproofing your cGXP Documentation from Audit Citations

Instructor: Chinmoy Roy

Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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

Instructor: David R Dills

Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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

Instructor: Mukesh Kumar and Herman Wong

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

Scale Up and Cycle Transfer for Lyophilization Cycles

Instructor: Jeff Schwegman

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. $150.00

Quality Management Systems for Medical Devices and IVDs

Instructor: David Lim

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

How to withstand an FDA audit of your facility

Instructor: Mukesh Kumar

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. $150.00

How FDA Inspection Observations are Reviewed for Regulatory Action

Instructor: Luis Chavarria

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. $150.00

Current Concepts & Challenges in Cloud Compliance

Instructor: Angela Bazigos

Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

GMP Vendor Audits

Instructor: Dr. James R Harris

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

cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

Instructor: David Lim

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

The Hitchhiker's guide to 483s and Warning Letters

Instructor: Angela Bazigos

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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

Instructor: Chris Doxey

The legislation came into force in 2002 and introduced major changes to the regulation of financial practice and corporate governance. Named after Senator Paul Sarbanes and Representative Michael Oxley, who were its main architects, it also set a number of deadlines for compliance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Implementing Design control for Medical Devices and IVDs

Instructor: David Lim

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

Computerized System Validation: Basic Concepts

Instructor: Harry Huss

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

Instructor: Jeff Schwegman

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. $150.00

Designing And Implementing The Quality System From Scratch

Instructor: Howard T Cooper

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

Instructor: David Lim

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

Instructor: Dr. James R Harris

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

Instructor: Harry Huss

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. $150.00

How To Conduct a Successful Process Validation

Instructor: Dr. James R Harris

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

Optimized Formulation Development for Lyophilized Products

Instructor: Jeff Schwegman

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

Instructor: David Lim

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. $150.00

21 CFR 11 Compliance for Excel Spreadsheets

Instructor: Angela Bazigos

In Dec. 2010, the 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. $150.00

Quality SOPs: Guidelines to developing and writing FDA Compliant Documents

Instructor: Chitra Edwin

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

Use GAMP to Surefire your CSV Audit

Instructor: Chinmoy Roy

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

FDA Investigations and Inspections

Instructor: Luis Chavarria

How FDA conducts investigations and inspections. Learn about the tools and procedures the FDA uses to conduct investigations and inspections from a former retired FDA Office of Regulatory Affairs officer.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

Critical SOPs for Clinical Sites

Instructor: Mukesh Kumar

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

Instructor: Chris Doxey

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

Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter

Instructor: Jeff Kasoff

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY!
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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

Instructor: Carlos M. Aquino

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

Instructor: David Lim

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

Instructor: Jeff Kasoff

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

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

Instructor: Carlos M. Aquino

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. $150.00

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

Instructor: David Lim

Medical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

How to Survive a DEA Inspection Series: Due Diligences of a Pharmacy

Instructor: Carlos M. Aquino

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

Instructor: Ron Schoengold

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

Writing USFDA-acceptable Clinical Trial Protocols

Instructor: Mukesh Kumar

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

Instructor: Dr Charles H Pierce

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

Lyophilization Process Development and Cycle Design

Instructor: Jeff Schwegman

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

Instructor: Mukesh Kumar

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

Instructor: David Lim

This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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

Instructor: Carlos M. Aquino

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

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

Instructor: Mukesh Kumar

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

Instructor: Dr Charles H Pierce

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

Instructor: David Lim

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. $150.00

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

Instructor: Carlos M. Aquino

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

Instructor: David Lim

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. $150.00

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

Instructor: Carlos M. Aquino

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. $150.00

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

Instructor: David Lim

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

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

Instructor: Carlos M. Aquino

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. $150.00

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

Instructor: David Lim

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. $150.00