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Virtual ACRP 2020, Part I

Session01 - Knock, Knock the FDA is here AGAIN: Be Prepared for a Regulatory Inspection


Apr 16, 2020 11:00am ‐ Apr 16, 2020 12:00pm



Credits: None available.

Description

Don’t miss the continuation of one of ACRP 2019’s most popular sessions! What do you do when a regulatory Agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure your systems are working the way you designed them. Examine FDA Inspections and how to prepare for the inevitable knock, discuss available resources and review responses received from 483s.

Speaker(s):

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

Credits

  • 1.00 - ACRP Credits

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Heather Reed
5/4/21 1:15 pm

Eric Pittman is a great speaker! I appreciate how realistic he is when talking about possible situations. I really like the way he explains the view of the FDA.