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Virtual ACRP 2021

RTC02Sept16 - Knock Knock...The FDA Is Here


Sep 16, 2021 12:15pm ‐ Sep 16, 2021 1:15pm



Credits: None available.

Description

Explore what it takes to be ready for the figurative knock on the door from FDA. Examine FDA Inspections and how to prepare for the inevitable knock, discuss available resources, and review responses received from 483s.

Learning Objectives:
  • Understand how the Bioresearch Monitoring Office is set up within FDA.
  • Understand the tools and resources available to you before and inspection and learn how an investigator will perform an inspection at your facility.
  • Learn the principles to responding to an FDA-483 or discussion points after the inspection.

Speaker(s):

  • Eric Pittman, MBA, Program Division Director, U.S. Food and Drug Administration

Credits

  • 1.00 - ACRP Credits

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