SBIA Education Events

Supporting Events from FDA CDER Small Business & Industry Assistance

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FDA REdI Annual Conference 2019
May 29-30, 2019

Agenda & Speaker Bios

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Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available. The current version is: Version 7, published on May 21, 2019.

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Speaker Biographies

This PDF file contains brief biographies of the FDA speakers participating in the conference.

Files, Certificate & Recordings

Both of the two links above include the slides for the Keynote and Plenary.

Click here to view CDER session recordings
on SBIA YouTube Channel

Session Recordings for the CDRH (Devices) Track:

Day One:

  • Keynote: Incorporating a Total Product Life Cycle Approach – William Maisel
    View Recording
  • A Case Study on Medical Device Determination and Product Classification – Kim Piermatteo
    View Recording
  • 510(k) Program Updates – Angela Demarco
    View Recording
  • Appropriate Use of Voluntary Consensus Standards and the Conformity Assessment Program – Scott Colburn
    View Recording
  • Facilitating Patient Access to Medical Devices: The Expanded Access, Early Feasibility Study, and Breakthrough Devices Programs – Maureen Dreher
    View Recording
  • Building Quality Clinical Data into Premarket Approval Applications (PMAs) – Donna Headlee
    View Recording

Day Two:

  • Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements – Joseph Tartal
    View Recording
  • Corrective and Preventive Action (CAPA) Case Study – Tonya Wilbon
    View Recording
  • Quality System: FDARA, 21st Century Cures Act, and Recent Postmarket Policy Updates – Vidya Gopal
    View Recording
  • Medical Device Single Audit Program (MDSAP) Overview – Kenneth Chen
    View Recording
  • FDA’s Import Requirements for Medical Devices – Terri Garvin
    View Recording
  • Overview of the FDA Exports Program for Medical Devices – Ethny Obas
    View Recording
  • FDA Medical Device Inspections – Maura Rooney
    View Recording