This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.
Over-the-Counter (OTC) Drug products do not require medical prescriptions, but must meet the respective FDA Drug Monograph requirements published in the Code of Federal Regulations (CFR), and thus the labeling of OTC Drugs differs substantially from that of labeling for all other drug (i.e., prescription) products. I will contrast the difference in the labeling of OTC & NDA drugs; I will present example OTC labels that the FDA deems acceptable; I will provide a few examples of firms that have deviated from FDA’s labeling for OTC products (some of which were likely cases of fraud); and I will answer questions dealing with correct labeling.
Areas Covered in the seminar:
- What are FDA's labeling requirements that differ between NDA vs. OTC Drug Labeling.
- Compliance parameters within FDA's 21 CFR 201 (esp. 201.66) and related sections crucial..
- Goals of FDA's Inspectors in reviewing open market & internet OTC labeling & advertising..
- Examples of acceptable OTC drug labeling.
- Examples of unacceptable OTC drug labeling.
- Enforcements due to illegitimate OTC drug labeling.
Who will benefit:
This webinar will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales. The employees who will benefit include:
- OTC drug manufacturing personnel responsible for OTC drug product labeling
- QA managers and personnel
- OTC drug operations managers and personnel
- Validation specialists
- Consultants
- Quality system auditors
Instructor Profile:
Alfredo J Quattrone, Prior to retiring in Dec 2006, Alfredo Quattrone, PhD, served in the Food and Drug Branch (FDB) of the California Department of Health Services for 19 years as a Staff Toxicologist, assisting with inspections of drug and device manufacturers within CA. During his last 8 years at FDB, Dr. Quattrone directed the State's team for FDA's accredited 3rd party persons medical device review unit, providing direct review support for 36+ device clearances for 510k premarket notification (PMN) submissions to FDA. Dr. Quattrone also coordinated the CA DHS Export Document program for processed foods & dietary supplements, medical devices, and drugs manufactured in California. Since early 2008, Dr. Quattrone has served as a consulting senior scientist affiliate to Auk Technical Services, Inc.
