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.
Why Should You Attend:
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
Course Provider
Alfredo J Quattrone,
