Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry"

OTC drug product for marketing


This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

•            Gain an understanding of how OTC drug products are regulated in the U.S.
•            Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
•            Understand the difference between the various pathways for commercializing an OTC drug product.
•            Learn how to identify and successfully navigate an OTC Drug Monograph.
•            Know when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
•            Know the required elements of a compliant OTC Drug Label.
•           Understand strategies for marketing and promoting OTC drug products, and for mitigating potential                             enforcement risks.
•            Learn the Rx-to-OTC Switch Process.
•            Review and evaluate several of FDA’s current OTC Monographs and Warning Letters

Areas Covered

•            Claims for drugs, devices, medical foods and cosmetics
•            NDA, ANDA and OTC Monographs for OTC Drugs
•            Rx to OTC Switches
•            Tamper Evidence and Poison Control
•            Branded Innovator, Branded Generic and Generics

Who will Benefit

•            Regulatory affairs managers, directors and associates
•            Compliance specialists
•            Marketing managers
•            Quality professionals
•            Document control specialists
•            Record retention specialists
•            Senior Managers / Business Owners
•            Product Managers
•            Labeling and Artwork Designers
•            Regulatory and Quality Professionals
•            Sales and Marketing Managers
•            R&D Managers and Staff

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Dr. Loren Gelber

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory requirements. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

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