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FDA Regulation of Over-the-Counter (OTC) Drugs
- Rx versus OTC
- How are OTC drugs regulated?
- Monographs
- NDA or ANDA
- Rx to OTC Switch
- Labeling
- GMPs
Overview of the webinar
Definitions of prescription (Rx) and OTC drugs will be presented. The three ways that FDA regulates OTC drugs, Monographs, Applications and Rx to OTC switches, will be discussed. Labeling rules for OTC products will be reviewed. Other requirements, including Registration, Drug Listing and Current Good Manufacturing Practice, will be covered. Examples from recent Warning Letters and FDA Inspectional Observations (483s) will be used to show what not to do.
Who should attend?
- Quality Experts
- Labeling Experts
- Regulatory Affairs Professionals
Why should you attend?
Both new and experiences OTC manufacturers will benefit from a review of the various FDA rules for OTC drugs. Knowledge of these rules and regulations is important for staying out of trouble with the FDA, which should be one of the main objectives of every drug manufacturer.
Faculty - Dr.Loren Gelber
Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.