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 ON DEMAND 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., 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., 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., 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.
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 corporations 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 Societys 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.
Karl Popp has lectured around the globe on new product development activities, GMPs and process validation, product life cycle management, and management of intellectual property. He has also served as an expert witness in matters before the U.S. federal courts.