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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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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
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:
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;
Monitoring and reporting adverse events and managing risk; and