- October 8, 2020
9:00 AM - 5:00 PM ET
Labeler Code Request
503B Compounder Product Reporting using CDER Direct
Soo Jin Park
Establishment Registration and Drug Listing Compliance Program
Join registration and listing staff in this workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions. Ask questions to FDA subject matter experts.
- Regulatory affairs professionals working on registration and listing submissions
- U.S. Agents
- Manufacturers, repackagers, relabelers, and private label distributers
- Submission vendors
- Labeler Code Requests
- Establishment Registration
- Drug Listing
- 503B Compounder Product Reporting using CDER Direct
- Establishment Registration and Drug Listing Compliance Program
- All sessions include a Q&A panel
- Drug Registration and Listing
- Structured Product Labeling
- NDC Directory
- Drug Establishments Current Registration
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 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.
Please contact firstname.lastname@example.org for all technical questions.
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|eDRLS-2020-Agenda.pdf||pdf (219.04 KB)|