In order to market dietary supplements and OTC drugs list in the U.S., reporting serious adverse events is required.
Why Should You Attend:
It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or FDA 483 observations audit issues.
Areas Covered in this Webinar:
This webinar will cover FDA guidance documents requirements for all manufacturers, packers, or distributors whose name appears on a drug or dietary supplement product label for adverse event reporting.
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
Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director Of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and as Associate Director of Marketed Product Support for Lederle Laboratories and Associate Director of Regulatory Affairs for Wyeth.
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