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Breakout

Breakout #1: The Mechanics of an FDA Inspection

Thursday, April 23, 2026
10:30 AM - 12:30 PM East Coast USA Time
Location: Franklin AB - 2nd Floor

    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

    View Slides

    • Speaker(s)

  • Bill Brodbeck

    Vice President, Regulatory Affairs
    STERIS Corporation

  • Eric Henry

    Sr. Advisor and Head of Quality Compliance
    Brooke & Associates

    View Slides

  • Melissa Michurski

    Assistant Director of Establishment Assessment Team 2, Center for Devices and Radiological Health (CDRH)
    FDA

  • CDR Cesar Perez

    Director, Division of Establishment Support, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA

  • Joseph Strelnik

    Branch Chief, Division 3 Northeast, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
    FDA

This session will include an FDA discussion on the “mechanics” of an inspection from inspection types, firm selection, initiation, conducting the inspection, closing meeting with or without 483, your response, routing of EIR for internal review, inspection classification, regulatory actions and your response if an action is taken. Additionally, industry representatives will review best practices for preparing for and preparing for, managing and responding to an FDA inspection.