Pharma / BiotechSkin & Cosmetics
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.
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:
Introductions & Agenda Review
Session 1. Global Cosmetic & Toiletry Market
Session 2. Regulatory Review of the Control of Personal Care Products in the World
Session 3. Introduction to Pharmaceutical cGMPs
Session 4. Cosmetic GMPs – A Trip around the World
Session 5. Global Current Affairs
Session 6. Workshop
Session 7. The Dreaded FDA Inspection
Session 8. Workshop - The Dreaded FDA Inspection
Upon completion of this course, the participants will be able to:
"The Course Director took time to answer questions throughout the course. The discussion opportunity this provided was very beneficial." Tammy V., OTC QE, Dow Corning Corporation
"A well-organized, thorough, well-paced overview of VMP, cGMP and validation requirements presented in a manner that anyone could understand. Well done!" Kirk J., Corporate Engineering Manager, Alberto Culver
"The Course Director kept the course interesting. He was extremely knowledgeable and answered all questions to the point." Shiv R., Sr. Scientist, J&J
"This course covered all aspects of validation and was very enlightening." Cynthia W., Validation Specialist, Colgate Palmolive
"The Course Director was knowledgeable and presented the material well." Eileen M., QA/QC Manager, Arkema, Inc.
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The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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