CDER Compliance Conference
January 14, 2021
In SBIA’s first conference dedicated to compliance, participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. Presenters will discuss questions from the audience after each presentation.
The agenda may be updated over time. The current version is Version 4, updated on January 9, 2021.
The speaker biographies document provides detailed information on the Conference speakers.
Links to recordings will be added as they become available.
- Keynote – Donald D. Ashley
- Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter – Djamila Harouaka
- Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates – Connie T. Jung
- A Glance at Drug Importation Requirements – Cristina Dar
- Risk Evaluation and Mitigation Strategies (REMS) Compliance Program – Haley Seymour
If you have questions regarding the content of the event or other CDER-specific information, please: