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Plenary

Investigator Insights

Friday, April 25, 2025
9:50 AM – 11:20 AM East Coast USA Time
Location: Regency Ballroom – 3rd Floor
This session is designed to provide attendees with valuable insights from FDA investigators based on their recent findings and experiences. Participants will gain an understanding of common compliance issues and regulatory expectations. This session also provides an opportunity for participants to ask questions and seek clarification from experienced FDA investigators.

    Moderator(s)

  • Monica Wilkins

    VP Regulatory, Quality & Compliance
    Abbott, Illinois, United States

    View Slides

    • 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 (Virtual)

  • 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 (Virtual)

  • CDR Tom Peter

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

  • KS

    Katelyn Staub-Zamperini

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

  • LCDR Mary Millner

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