This Good Manufacturing Practices training covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. Current Good Manufacturing Practices (cGMPs) are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the GMP course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution.
Each section of 21 CFR 211 (Current Good Manufacturing Practices [CGMP] for Finished Pharmaceuticals) will be covered interspersed with references from 21 CFR 600/610 (Biological Products: General) and 21 CFR 820 (Quality Systems Regulations). Although CGMP refers to 21 CFR 210/211 the other Parts (600 and 820) rely on Part 211 as well. In addition to the above, ICH, EU, and other comparisons will be made in order to provide a complete understanding of the regulations.
The GMP course provides a complete overview of the industry requirements as specified by the FDA.
For more information and registration visit: www.cfpie.com