"Compared to courses by other providers this was much better and more comprehensive. The supporting case studies kept the audience fully engaged. The course director was very experienced and delivered interesting real-life examples."
Ruben C., Director of Quality, Universal Beauty Products
"The experience of the Course Director was critical to this great course! She added excellent insight. The case studies were very enjoyable."
Carl R., Supplier Quality Compliance Manager, Clorox
"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. She was extremely knowledgeable and answered all questions to the point."
Shiv R., Sr. Scientist, J&J
"The Course Director was knowledgeable and presented the material well."
Eileen M., QA/QC Manager, Arkema, Inc.
Personal care consumer products in the US encompass a broad spectrum of categories, ranging from food/supplements to cosmetics to OTC drug products. They are mainly regulated by the FDA 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 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.
Both finished dietary supplement products and dietary ingredients are regulated by the FDA as stipulated by the Dietary Supplement Health and Education Act of 1994. Dietary supplements cGMP compliance, such as manufacturing, packaging, labeling and marketing, is required under 21 CFR part 111.
This course aims to provide the participants with a useful, step-by-step guide in setting up a comprehensive GMP program. It outlines the international development and harmonization of GMPs relevant to these over-the-counter consumer personal care 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 15 hour course focuses on the regulatory requirements of good manufacturing practices for various over-the-counter drugs and consumer/personal care products in the US while also referencing key international counterpart. It is designed for professionals in the personal care (e.g., drugs, cosmetic, and consumer products) industries engaged in all aspects of product development including
Upon completion of this course, the participants will be able to:
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
"Compared to courses by other providers this was much better and more comprehensive. The supporting case studies kept the audience fully engaged. The course director was very experienced and delivered interesting real-life examples."
Ruben C., Director of Quality, Universal Beauty Products
"The experience of the Course Director was critical to this great course! She added excellent insight. The case studies were very enjoyable."
Carl R., Supplier Quality Compliance Manager, Clorox
"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. She was extremely knowledgeable and answered all questions to the point."
Shiv R., Sr. Scientist, J&J
"The Course Director was knowledgeable and presented the material well."
Eileen M., QA/QC Manager, Arkema, Inc.
Registrant Information:
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