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.
INTENDED AUDIENCE
Regulatory affairs professionals working on registration and listing submissions
U.S. Agents
Importers
Manufacturers, repackagers, relabelers, and private label distributers
Submission vendors
TOPICS COVERED
Labeler Code Requests
Establishment Registration
Drug Listing
503B Compounder Product Reporting using CDER Direct
Establishment Registration and Drug Listing Compliance Program
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.
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and regular updates for regulated industry through its workshops, webinars, electronic notifications and more.
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