Center for Professional Innovation & Education, Inc., Malvern, PA
October 20 & 21, 2015
Course DescriptionPersonal 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.
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Invited Speakers:
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Wen SchroederWen Schroeder is the founder and president of SEKI Cosmeticals. With 20+ years of industrial experience, 30 US patents and author of numerous publications, Ms. Schroeder is an internationally recognized lecturer on cosmetic science & regulatory affairs. Her lecture topics cover a wide range of areas including chemical management and biocide regulations, food, drug and cosmetic law. She is a key expert for numerous cross-governmental aid programs including the ASEAN-EU Programme, under the European Commission, for Regional Integration Support in cosmetic & pharmaceutical GMP and testing. Ms. Schroeder is scientific advisor to Taiwan External Trade Development Council and previously taught courses addressing cosmetics, food, OTC drugs, biocides and chemical management topics. She served on the Personal Care Products Council and is active in the Society of Cosmetic Chemists and the Regulatory Affairs Professional Society. Ms. Schroeder is the editor of a newly published book, Sustainable Cosmetic Product Development by Allured Books, which is the first comprehensive technical reference work in this field for the cosmetic and personal care industry.
Ms. Schroeder teaches the following four courses for CfPIE:
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