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:
Regulatory Consultant, EAS Consulting Group and NS Consulting
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. She currently works as a regulatory consultant.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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