- October 5, 2021
1:00 PM - 2:30 PM ET
ABOUT THIS WEBINAR
Please join us as FDA will:
- Discuss enhanced drug distribution security requirements that go into effect in 2023 under the Drug Supply Chain Security Act (DSCSA).
- Explain how enhanced drug distribution security will help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
- Summarize updates on implementation of supply chain security requirements under the DSCSA.
- Pharmaceutical supply chain and distribution
- Drug traceability and verification
- Supply security requirements under the DSCSA
- Enhanced drug distribution security under DSCSA
- Trading partners (Manufacturers, Repackagers, Wholesale Distributors, Dispensers (primarily Pharmacies), and Third-party Logistics Providers (3PLs))
- Regulatory affairs professionals working on compliance with DSCSA requirements
- Solution providers or consultants working on DSCSA requirements
- Other Federal or State regulators
Connie Jung, RPh, PhD
Senior Advisor for Policy
Office of Drug Security, Integrity and Response (ODSIR) | Office of Compliance (OC) | CDER | FDA
Abha Kundi, JD, MPH
Division of Supply Chain Integrity | ODSIR | OC | CDER | FDA
- FDA Drug Supply Chain Security Act (DSCSA) Webpage
- DSCSA Laws and Policies (FDA Guidance for Industry)
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This course has been:
- pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- 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.
- pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- 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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