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Plenary

Investigator Insights

Friday, April 24, 2026
10:00 AM - 12:00 PM East Coast USA Time
Location: Regency Ballroom - 3rd Floor

    Moderator(s)

  • Monica Wilkins

    VP Regulatory, Quality & Compliance
    Abbott

    • Speaker(s)

  • CB

    Christina Bigham

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

  • 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

  • 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

  • Jeffrey Wooley

    Compliance Officer in Establishment Assessment Team 3, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA

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 to enhance production, manufacturing, and importation processes.