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.
Continuing Education Credit
- has been pre-approved by RAPS as eligible for up to 4.25 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.
- Continuing education certificates are available only for those who attend real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.
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: