FDA REdI Annual Conference
August 25, 26, 27 & 28, 2020
Continuing Education Credit
- has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
- Real-time attendance is required for attendance certificates which are only available during the three weeks after the event.
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is Version 9, updated on August 25.
This PDF file contains brief biographies of the FDA speakers participating in the conference.
CDER (Drugs) session recordings will be added to the SBIA YouTube Channel once they have been processed.
The CDRH (Devices) session recordings will be linked below once they have been processed.
- Plenary – John Concato and Soma Kalb
- Getting Started: CDRH Resources for You – Donna Headlee
- Benefit-Risk Throughout the Medical Device Lifecycle: Premarket, Postmarket, and Compliance – Kimberly Brown Smith
- 510k Device Modifications: Case Study – Melissa Hall
- A New Way to 510k: The Safety and Performance Based Pathway – Jason Ryans
- De Novo Classification: An Alternative Pathway to Market for New Device Types – Sergio de del Castillo
- Considering Cybersecurity in Device Development and Factors Influencing Successful Premarket Review – Lisa Simone
- Design Controls: Case Study – Joseph Tartal
- Production and Process Controls: Case Study – Vidya Gopal
- Case for Quality – Francisco Vicenty
- Medical Device Single Audit Program (MDSAP) – Kenneth Chen
- Risk Management Within A Quality System – Tonya Wilbon
- eMDR System Overview and Submission Walkthrough – Evan Jacobs
- FDA Medical Device Inspections – Laureen Genuisz
If you have questions regarding the content of the event or other CDER-specific information, please: