Course Description

cGMP for Personal Care, Cosmetic and OTC Products

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Course ID 2615

In-Person Course

Who Should Attend?
This course is intended for all those involved in the development and manufacture of cosmetics, OTC drugs and personal care products especially:

• Research and Product Development Personnel
• Production Personnel
• Quality Control Personnel
• Quality Assurance Personnel
• Quality Systems Auditors

Research, Production, Legal and Quality Operation and management professionals who are involved and or responsible for the quality of products produced and marketed to consumers would additionally benefit from this course.

Course Description
With public trust of drug manufacturers being challenged, the importance of following GMPs has never been more important. GMP compliance is not only a regulatory requirement, but a business necessity!

This 12-hour intensive course will provide an in-depth overview of Current Good Manufacturing Practices for personal care, cosmetic and OTC products and will highlight how the Quality Systems approach can support regulatory compliance not only in the United States, but also the European Union. The course is designed to assist formulators, production personnel, quality control and assurance teams, and management understand GMP regulations, their implementation, and the impact they have on all facets of a product’s life.

Through a review of each section of the Quality Systems Manual, participants will gain insights to the processes affecting the writing, issuance and maintenance of SOPs and how they can affect day to day operations, including GMP requirements for facilities, personnel training, equipment qualification activities, process validation, component and product specifications, packaging and labeling controls, laboratory activities, warehousing and shipping monitoring, the importance of process water system validation and care, complaints and recalls, and handling FDA inspections.

Course Director
Karl F. Popp, R. Ph., Principal, KPopp Consulting, LLC

Karl Popp founded KPopp Consulting, LLC in 2010 as a consulting firm providing services to pharmaceutical, cosmetic and allied industries. He also is a practicing retail pharmacist.

During his career he has been responsible for the development of products that have generated over $2 billion in sales.

From 1989 to 2008 he was associated with Stiefel Laboratories as Director of Product Development, and later as Senior Director of Special Projects coordinating external manufacturing, global research activities, and managing the corporation’s intellectual property estate.

Prior to joining Stiefel, he was a Scientist and Project Manager for the Sterling-Winthrop Research Group. He earned his B. S. in Pharmacy from the Albany College of Pharmacy, an M.B.A. from Rensselaer Polytechnic Institute and is licensed to practice pharmacy in NY.

He has been active in the Society of Cosmetic Chemists in coordinating local educational seminars and is a past chair of the New England Chapter. He served on the National Committee on Scientific Affairs (1994-96), as Vice President-elect (1997), Vice President (1998), and as the Society’s President in 1999. Mr. Popp was elected a Fellow of the Society in 2002 and granted Emeritus status in 2015. He is an inventor, an author and a scientist.

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