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Breakout

Breakout #2: Quality Beyond the Factory's Walls: Managing Supplier Risk and Quality From Off-the-Shelf to Custom Contract Manufactured Products

Thursday, April 23, 2026
1:30 PM - 3:00 PM East Coast USA Time
Location: Franklin CD - 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

  • John Krug

    Executive Director and Site Quality Leader of Indianapolis Device Manufacturing
    Eli Lilly and Company

  • 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

    • Speaker(s)

  • James Brogan

    Sr. Director of Quality Assurance
    West Pharmaceutical Services

    View Slides

  • Maria Hult

    Subchapter Lead, Product & Service Partnering
    Roche Diagnostics

  • Debbie Reese

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

    View Slides
  • 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

The manufacture of medical devices is increasingly reliant on distributed value chains, with manufacturing steps of varying complexity (ranging from off the shelf raw materials to full custom contract manufacturing of finished devices) outsourced to suppliers. This 90 minute session will clarify the regulatory requirements for supplier risk and quality management. Industry experts will describe successful strategies for satisfying these requirements while enabling the manufacture of high quality medical devices to meet market needs.