In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
Why Should You Attend:
This webinar will cover requirements for all manufacturers, packers, or distributors whose name appears on a drug or dietary supplement product label for adverse event reporting. The program will also include discussions on FDA notification requirements, determination of what constitutes a serious adverse event, procedures for filing reports, and record keeping requirements.Areas Covered in the Webinar:
- Understand adverse event reporting requirements for OTC drugs and dietary supplements
- Understand how a serious adverse event is determined
- Learn correct procedures for filing FDA notifications
- Be able to implement FDA recordkeeping requirements
Who Will Benefit:
- Regulatory affairs managers
- Directors and associates
- Compliance specialists
- Marketing managers
- QA managers
Course Provider
Norma Skolnik,
