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The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
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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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Webinar Training Pass
Description: Regulatory specialist Gina Ross shows how to create a content development and organization strategy for developing electronic Common Technical Documents and how to develop authoring SOPs that ensure global compliance. Ross discusses:
- 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.
cGMPs From An Auditor's Perspective
69 minutes
Description: Certified quality auditor Robert Schiff describes his experiences as a veteran of numerous GMP inspections and points out the 10 most commonly noted violations. Schiff discusses:
- 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
Cleaning Validation Risks
98 minutes
Description: Validation expert Rich Yeaton reveals the front-line cleaning validation techniques needed to stay FDA compliant. Yeaton discusses:
- 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
Description: Dietary supplements expert Ivan Wasserman discusses how FDA adverse event reporting rules apply to OTCs and supplements just as they do to prescription drugs and explains all facets of the reporting process, including:
- 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
Description: Clinical trial specialist Charles Pierce educates research facilities and investigators on how to identify and report on adverse events that occur in their trials and make sure they comply with FDA’s and other authorities’ requirements. Pierce covers:
- 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
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