GMPs for OTC and Cosmetic Products – US and Global Requirements

Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

Personal care products in the US often fall into two regulatory product categories regulated by the FDA: the cosmetic and the OTC products. Both are regulated under the Federal Food, Drug and Cosmetic Act (FFD&C Act). As is required under Section 501(a)(2)(B) of this act, drugs manufactured in the US must conform to current good manufacturing practices (cGMPs), prescription and OTC alike. GMPs outline regulatory requirements for the manufacturing, processing and packaging of pharmaceutical products to ensure their safety and effectiveness. The act further stipulates that cosmetics introduced into interstate commerce should not be adulterated or misbranded.

The cosmetic good manufacturing practice is a set of manufacturing guidelines to ensure the safety and quality of cosmetic products. Rigorous adherence to good manufacturing practice minimizes the risk of adulteration or misbranding of cosmetics. This course outlines the international development and harmonization of GMPs relevant to cosmetic and OTC products with detailed discussion in key areas of concern ranging from the facilities to personnel to material control to corrective/preventative measures and recordkeeping.
Who Should Attend

This course focuses on the regulatory requirements of good manufacturing practices for OTC and cosmetic products in the US while also referencing key international counterpart to provide a well rounded world view for the participants. It is designed for professionals in the personal care, cosmetic, chemical application and pharmaceutical industries engaged in all aspects of personal care product development, including the raw material suppliers, in the following areas:

Research & Development
Technology, Formulation & Product Development
Marketing & Technical Sales
Regulatory Affairs
QA & QC Professionals
Business Decision Makers