Adverse Event Reporting Rule for OTC Drugs, Dietary Supplements & Cosmetics
About this course
Watch RECORDED Session both for Just $149
Training Duration: 60 Minutes
In order to market dietary supplements and OTC drugs in the U.S.A. reporting serious adverse events is mandatory. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid refusal of product entry into the U.S. or an FDA warning letter or FDA 483 audit issues. Serious Adverse Event reporting will also soon be required for all Cosmetics and its essential that Cosmetic companies learn what will be required of them and how to comply.
- Understand Serious Adverse Event (SAE) labeling requirements
- Review current AE reporting requirements for OTC drugs and Dietary Supplements
- Cover coming SAE requirement for Cosmetics
- Understand how a Serious Adverse Event is determined by FDA
- Learn correct procedures for filing FDA notifications
- Be able to implement FDA Adverse Event recordkeeping requirements
Why You Should Attend :
This event will cover Adverse Event requirements for all manufacturers, packers, or distributors of OTC drug or dietary supplement products for mandatory serious adverse event reporting. Included will be FDA labeling and notification requirements, determination of what constitutes a serious adverse event, procedures for filing reports and all FDA record keeping requirements. Important future requirements for reporting Cosmetic Adverse Events will also be covered since AE reporting for Cosmetics is encouraged by FDA and will soon be mandatory.
Who Should Attend:
- Regulatory Affairs managers and associates in the Personal Care Products & OTC drug industries
- Consumer Healthcare company QA & product managers
- Dietary Supplement product managers
- Cosmetic firm product managers
At the Q&A session following the live event, ask a question and get a direct response from our expert speaker.
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*Recording will be available after the completion of Live session.