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Strategic Partner

July 19, 2018 - July 19, 2018

Trial Master File (TMF): FDA Expectations from Sponsors and Sites

United States

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Event Details

Begins: July 19, 2018

End: July 19, 2018

Event Location: United States

Website: https://www.compli..5759-prdw

Event Organizer

Event Organizer: ComplianceOnline

Contact Person: Sreeraj Mathilassery

Phone Number: +1-888-717-2436

Website: https://www.complianceonline.com/

Overview

This Trial Master File training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using check-lists and case studies to highlight common deficiencies and potential solutions.

Why Should You Attend:

This webinar is very much essential for Professionals involved in a clinical trials, either as a clinical site or a sponsor/CRO as it will provide valuable suggestions about which documents are essential according to FDA requirements for drugs, biologics and medical devices. The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions and best practices of implementation related to set up, maintenance and quality control of the TMF for drugs, biologics and medical devices.

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