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Breakout

Breakout #2: De-Mystifying Verification and Validation of Manufacturing Processes

Wednesday, April 22, 2026
12:40 PM - 1:40 PM East Coast USA Time
Location: Franklin CD - 2nd Floor

    Moderator(s)

  • Susan Matthias

    Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
    FDA

    View Slides

    • Speaker(s)

  • Michelle Glembin

    Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
    FDA

  • Tom Peter

    Senior Operations Officer, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Office of Inspections and Investigations (OII)
    FDA

Verification and Validation of Manufacturing Processes: Hear from FDA investigators about how to decide if a process requires validation and best practices for conducting validations. This breakout session will go through case studies of manufacturing process validation, discuss risk-based decision making and how it applies to verification & validation, and de-mystify attendees understanding of when verification is acceptable and when a full validation is required.