The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
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Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
- Key areas of risk and potential red flags;
- Responding to public and non-public unsolicited requests for information;
- Implications of the responsible corporate officer doctrine; and
- How a violation becomes a false claims case.
Presentation: Download the presentation
Speakers: James Ravitz, Partner, Arent Fox LLP and Stephanie Trunk, Associate in the Health Law Group, Arent Fox LLP
- Pediatric testing; and
- When a regulated entity should construct its own defensible compliance programs instead of waiting for overt FDA direction.
Presentation: Download the presentation
Speakers: Erika Lietzen, Partner, Covington & Burling and Laura Sim, Associate in Food & Drug practice group, Covington & Burling
- How to better understand and produce compliant 510(k) content;
- How to handle a predicate event; and
- How to understand when a regulated entity should issue a 510(k).
Presentation: Download the presentation
Speakers: Neil O'Flaherty, Principal, Olsson Frank Weeda Terman Matz PC (OFW Law); Evan Phelps, Principal, OFW Law and Nancy Mathewson, Associate, OFW Law
- Key differences between Parts 7 and 806 when it comes to device recall strategy;
- Unique challenges to accurate reportability; and
- Ways to evaluate the proper recall criteria for a devicemaker.
Presentation: Download the presentation
Handout: 21 CFR Part 806 Process Flow
Speaker: Gordon B. Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest
- An overview of FDA inspections and regulatory actions;
- Review of the FDA’s compliance program for dietary supplements;
- What the agency considers the major deviations that often result in warning letters; and
- Strategies for responding to warning letters and 483s.
Presentation: Download the presentation
Speakers: Dean Cirotta, Vice President, EAS Consulting Group and William Ment, Contract Consultant, EAS Consulting Group
- The essential components of a complaint management system;
- How to handle failure investigations; and
- Adverse event evaluation and recordkeeping.
Presentation: Download the presentation
Speaker: Susan Reilly, Owner and Principal Consultant, Reilly & Associates LLC
- How to choose the best locations for EM;
- Making the case to regulators for the choice;and
- Key trendsof 483 citations from FDA and EMA.
Presentation: Download the presentation
Speaker: Kenneth Christie, COO, Consulting Services at VTS Consultants Inc.
Description: Supplier management expert John Avellanet covers regulatory requirements for data management, supplier validation review,SOPs and records closeout. He answers important questions regardingthe:
- Interrelationship between 21 CFR Parts 11 and 820;
- Supplier accountability;
- FDA enforcement trends; and
- How “paper audits” can be the first foundation for a strong compliance program, and how to identify which records to retain and required SOPs.
Presentation: Download the presentation
Speaker: John Avellanet, Managing Director, Cerulean Associates LLC
- Dedicated washrooms;
- Material sampling rooms;
- Production suites and other support rooms; and
- Air handling, engineering controls, and systems and processing, including certification to ISO standards.
Presentation #1: Download the presentation from Kevin Rosenthal
Presentation #2: Download the presentation from Stephanie Wilkins
Speakers: Kevin Rosenthal, Director of Manufacturing, Pharmatek Laboratories Inc. and Stephanie Wilkins, PE, Lean Six Sigma Green Belt
- Theory and methods in adaptive design;
- Algorithm-based designs vs. model-based designs; and
- Future view of model-based design’s impact on the biopharma industry.
Presentation: Download the presentation
Speakers: Olga Marchenko, Vice President, Quintiles Inc. and Seth Berry, Director of Clinical PK-PD Modeling and Simulation, Quintiles Inc.