cGMP for Personal Care, Cosmetic and OTC Products

This 2-day 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 in understanding 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.