This book presents Current Good Manufacturing Practice (CGMP) requirements as set forth by the FDA. Supplemented with a handy keyword index, it provides, in a pocket-sized format, the complete and unaltered text of CFR Part 820. The index at the end of the book helps readers find the exact section of the reg they need. The comb binding makes it easy to use and the 3 3/4 inch by 5 1/2 inch size makes it easy to take from the desk top to the shop floor. It is a cost-effective tool for use in documented GMP training programs, for suppliers and vendors who need to be FDA compliant, and technicians who must secure adherence to US FDA regulations.

The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements, and for each clinical investigator, nurse, and technician to help assure compliance to clinical trial protocols. A keyword index can be found at the end of each booklet.

Supplemented with a convenient keyword index, this book provides a pocket-sized verbatim reproduction of key US FDA regulations. It presents the requirements as set forth by the FDA CFR 21 Parts 807, 812, and 814 to sell or distribute medical devices, including the pre-market approval requirements for the devices. The easy-to-use format that puts the exact section of the reg required by medical device manufacturers within easy reach. This is the perfect low-cost tool for employees as part of documented training programs; suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements; and technicians charged with ensuring adherence to US FDA regulations.

The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.