REdI Annual Conference 2019
FDA REdI Annual Conference 2019
May 29-30, 2019
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.
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.
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