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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
- Who should report and to whom?
- What information should be reported;
- Exemptions for “exceptional circumstances;” and
- How to report follow-up information.
Presentation: Download presentation
Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.
- When DILI is most likely to occur;
- Drug factors in DILI outcomes;
- Phase I vs. Phase II reactions; and
- A comparison of compounds with significant and nonsignificant hepatic metabolism.
Presentation: Download presentation
Speaker: Einar Bjornsson, Professor of Gastroenterology and Hepatology, Landspitali University Hospital
- Training needed to conduct effective CCE research;
- Learning from programs already in use in the EU, Canada and Australia;and
- Integrating medical statistics and health economics to create a value analytic model.
Presentation: Download presentation
Speaker: Josh Feldstein, President, Joint Center for Applied Value Analysis and Principal, MarCom Group International
- Understanding the FDA’s bioequivalence requirements;
- How to craft an ANDA that directly addresses the patent infringement issue; and
- Strategies for addressing exclusivity grants.
Presentation: Download presentation
Speaker: Chad Landmon Esq., Partner, Axinn Veltrop & Harkrider LLP
- Documents inspectors will request;
- Information inspectors are not authorized to look at;
- Agency priorities and what FDA inspectors look for; and
- Potential post-inspection actions.
Presentation: Download presentation
Speakers: Frederick H. Branding RPh JD, Principal Attorney, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. and Cathy L. Burgess, Partner, Olsson, Frank, Weeda, Terman, Bode and Matz P.C. Health Care Group
- The impact of the current research landscape on indemnification;
- IRB and Ethics Committee requirements; and
- Factors to consider when deciding the scope of indemnification needed for a clinical trial.
Presentation: Download presentation
Speaker: Joan Antokol, Managing Partner, Park Legal LLC
- Mapping the process flow in an integrated complaint management system;
- Servicing records and reports;
- Recording and reporting on complaint investigations; and
- Overlapping reporting requirements for MDRs and Corrections & Removals.
Presentation: Download presentation
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
- The differences from the perspectives of manufacturers, user facilities and importers;
- Premarket and postmarket reporting requirements; and
- Reporting voluntary recalls and corrections and removals.
Presentation: Download presentation
Speakers: Steven Datlof MD JD, Partner, Hogan Lovells and Elisabethann Wright BL, Partner, Hogan Lovells International
- Developing a pre-audit assessment plan;
- Elements of a safety policy; and
- Roles and responsibilities for staff involved in the inspection.
Presentation: Download presentation
Speaker: Anne Maczulak PhD RQAP-GLP, Principal Consultant, Acorn GLP Consulting
- The principals and scope of Annex 11;
- Differences between Annex 11 and Part 11;
- How the revised rules incorporate standard IT practices; and
- How they differ from the original Annex 11 provisions that had been in place for nearly 20 years.
Presentation: Download presentation
Handout #1 - Comparison of FDA’s Part 11 and the EU’s Annex 11
Handout #2 – Verification vs. Validation: FDA’s Expectations and Why The Difference Matters
Speaker: Martin Browning, President and Co-Founder, EduQuest