cGMPs for Cosmetics & OTCs

Course Summary

The course will provide an overview of current Good Manufacturing Practices for both Cosmetic and OTC products.  The course is presented to educate and review salient aspects of the cGMP regulations for drug products and pending GMP regulations for cosmetics. Formulators, production personnel, managers, and quality team members will benefit from the practical, Quality Systems approach used to describe GMP requirements and activities.

Who Should Attend

The course is designed not only to introduce GMPs to those new to the industry, but also as a review for those experienced in this regulatory area. Participants will leave with an appreciation of the intent of the GMP regulations and knowledge of factors impacting the organization and personnel, buildings and equipment, cleaning and sanitization activities, component and process controls, laboratory and production documentation, packaging and label controls, as well as complaint and recall management. Participants will also learn about preparing SOPs, components of a stability program, importance of process water for manufacturing, what is meant by process validation, and the importance of internal and external audits.

Program Contents

• Review of Regulations and the History of GMPs
• MoCRA: What We Know Now and When We’ll Know More
• Organization and Personnel
• Buildings and Facilities 
• Equipment and Calibration
• Cleaning and Sanitization
• Control of Components
• Laboratory and Production Documentation
• Production and Process Controls 
• Packaging and Label Controls 
• Stability Testing
• Warehousing and Distribution of Product
• Laboratory Controls 
• Writing SOPs
• Process Water Systems
• Management of Complaints and Recalls
• Validation Activities
• Auditing, Internal and External, for Compliance

Instructor: Karl Popp R. Ph.

Format: Online

Dates: 

• Monday, November 13, 2023
  (11:00am - 2:30pm ET)
• Tuesday, November 14, 2023 
  (11:00am - 2:30pm ET)
   

REGISTRATION CLOSED

About the instructor

Karl Popp

Karl F. Popp, R. Ph. 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.  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 in 1989, he was a Scientist and Project Manager for the Sterling-Winthrop Research Group. During his career he has been responsible for the development of products that have generated over $2 billion in sales. He has over 40 years or experience in laboratory and GMP production operations.   He earned his B. S. in Pharmacy from the Albany College of Pharmacy, an M.B.A. from Rensselaer Polytechnic Institute. Karl is a member of the Society of Cosmetic Chemists and a licensed pharmacist (NY).   He has been active in the SCC in coordinating local educational seminars and as past New England chapter chair, has served on the National Committee on Scientific Affairs and as the Society’s President in 1999. Karl was elected a Fellow of the Society in 2002 and an Emeritus Member in 2015.   He is an inventor, an author and a scientist. His interests encompass topical, oral, inhalation, and parenteral dosage forms in addition to various therapeutic categories. During his over 40 years in the industry, Karl Popp has lectured around the globe on new product development activities including GMPs, regulatory strategies, product pipeline efforts, process validation, product life cycle management, and management of intellectual property.