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Plenary

FDA Mock Inspection

Thursday, April 24, 2025
2:25 PM – 4:25 PM East Coast USA Time
This active role play session will simulate an FDA inspection from start to finish covering the essential elements of the QSIT approach. The audience will actively participate during the mock inspection with interactive polling and Q&A.

    Moderator(s)

  • Phil Pontikos

    Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)
    FDA

    • Speaker(s)

  • LG

    Laureen Geniusz

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

  • Benjamin Dastoli

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

  • Bill Brodbeck

    Vice President, Regulatory Affairs
    STERIS Corporation, Ohio, United States