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.
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.
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Webinar Training Pass
- Quality System Regulation requirements for purchasing;
- Supplier qualification;
- Scope and primary elements of a supplier agreement; and
- Working with third-party suppliers.
Presentation: Download presentation
Handout: Download handout
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Presentation: Download presentation
Speakers: David Clissold, Director, Hyman, Phelps & McNamara and Nisha Shah, Associate, Hyman, Phelps & McNamara
- How to train staff to write eCTDs;
- Managing the document throughout its lifecycle; and
- The decision-making process for most effective integration of regulatory strategies and eCTD lifecycle management
Presentation: Download presentation
Speaker: Gina Ross, Manager of the Regulatory Publishing Department, Beckloff Associates Inc.
- CAPA failures;
- Lack of out-of-specification, nonconformance and deviation investigations;
- Inadequate complaint handling; and
- Failure to follow established SOPs.
Presentation: Download presentation
Speaker: Robert Schiff Ph.D., CEO, Schiff & Company
- Developing and implementing a Cleaning Validation Master Plan;
- The three key parts of a cleaning validation program;
- Cleaning acceptance criteria; and
- Appropriate analytical methods.
Presentation: Download presentation
Speaker: Rich Yeaton, President, East Coast Validation Services LLC
- How to identify adverse events;
- Collecting data on the event;
- Documenting the event; and
- Reporting procedures.
Presentation: Download presentation
Speaker: Ivan Wasserman, Partner, Manatt Phelps & Phillips LLP
- Definitions and types of adverse events;
- Investigators’ responsibilities;
- Monitoring and reporting adverse events and managing risk; and
- Common mistakes in reporting.
Presentation: Download presentation
Handout – Adverse Event Study Medication Relationship
Speaker: Charles H. Pierce MD, PhD, FCP, CPI, Pierce One Consulting