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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

FDA Inspections in 2019: Are You Prepared?

Marcelo Trevino (Senior Vice President, Regulatory Affairs & Quality Systems, Applied Medical)

Raymond Brullo, MD (Compliance Officer, FDA)

Location: 210D

Date: Thursday, February 7

Time: 11:00am - 11:45am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

We’ll take a look back at 2018 and explore FDA inspections, warning letters, and recalls finding out what medical device companies should watch out for in 2019. You can successfully meet any FDA inspection’s expectations with appropriate planning, timely communication, and transparency. This session will help you understand how to be prepared and let you know what to expect when the agency comes knocking at your manufacturing site.

Topics to be covered include:
  • A look back at 2018 inspections and recalls, and the areas where FDA put focus
  • What to expect during an inspection
  • Getting ready for your inspection
  • Addressing 483s post-inspection
  • How to collaborate with FDA to ensure compliance with FDA Law

Presentation File

FDA_Inspections_in_2019_Are_You_Prepared.pdf