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What FDA Looks for During Inspection


Marcelo Trevino (Senior Vice President of Regulatory Affairs and Quality, Applied Medical)

Location: 210D

Date: Thursday, February 8

Time: 1:15pm - 2:30pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

FDA inspections are a nerve-wracking prospect that medical device manufacturers must be ready for at all times. This session will help ensure you know what to expect when the agency comes knocking.

Topics to be covered include:

  • Best practices for being “audit/inspection ready” all the time
  • Effective methods for managing an FDA inspection including preventative measures you can put in place
  • Understanding how to respond to a Form 483 when conditions may violate FDA requirements
  • What to do if you don’t agree with FDA’s actions
  • Collaborating with the agency to ensure responses will meet expectations