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ACRP 2019 OnDemand


5015 - Knock, Knock....FDA is here; Be Prepared for a Regulatory Inspection


Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am


Credits: None available.

Non Member: $75.00
Members: $15.00

Description

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. We will briefly look at FDA Inspections and how to prepare for the inevitable knock, and discuss resources available to you.

Learning Objectives:

  • Learn how to prepare for a regulatory inspection, before the “knock on the door”.
  • Learn what should be in your quality system to be prepared.
  • Understand what resources are available for you prior to, during, and after regulatory inspections.

Speaker(s):

  • Eric Pittman, Program Division Director, FDA, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

Credits Available


Knock, Knock....FDA is here; Be Prepared for a Regulatory Inspection Exam

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