- January 14, 2021
9:00 AM - 3:30 PM ET
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.
- Compounding: Cleanrooms and cleanroom behaviors: why they matter
- Drug importation requirements
- Risk Evaluation and Mitigation Strategies (REMS) compliance program
- Drug Supply Chain Security Act implementation (DSCSA) implementation updates
- Importers and exporters of pharmaceutical products
- Regulatory affairs work on REMS
- Outsourcing facilities
- Boards of Pharmacy
- Drug distribution supply chain
Donald D. Ashley
Office of Compliance (OC) | CDER
Djamila Harouaka, PhD
Division of Drug Quality III | Office of Manufacturing Quality | Office of Compliance | CDER
Connie T. Jung, RPh, PhD
Senior Advisor for Policy
Office of Drug Security | Integrity and Response | CDER
LCDR Cristina Dar
Imports Team Lead
Office Drug Security, Integrity and Response | CDER
Haley Seymour, MS
Consumer Safety Officer
Division of Enforcement and Postmarketing Safety | Office of Scientific Investigations | Office of Compliance | CDER
Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:
- has been pre-approved by RAPS as eligible for up to 8 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.
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|Agenda_Compliance2021_pdf||pdf (103.82 KB)|