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Breakout

Breakout #3: Are You Correctly Assessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?

Wednesday, April 23, 2025
2:55 PM – 3:55 PM East Coast USA Time
A facilitated discussion about asking the right questions to assure you meet regulatory requirements, communicating and disseminating information across functions and facilities, and registering appropriately.

    Moderator(s)

  • Gina Brackett

    Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA (Invited)

    • Speaker(s)

  • Monica Wilkins

    VP Regulatory and Quality
    Abbott

  • Kim Shoemaker

    Senior Director, Global Regulatory Affairs
    Johnson & Johnson MedTech