Documentation Practices: A Complete Guide to Document Development and Management of GMP and ISO 9000 Compliant Industries

This book is written for the industry that develops, manufactures, and markets medical products for human and veterinary use. This industry is regulated by the FDA. The documents and the document management systems presented in this text, however, can be applied to any regulated industry, such as the EPA, USDA, or OSHA, or to any industry that develops or manufactures products for human use.

Carol DeSain is an independent consultant with 22 years' experience in product development, manufacturing, and quality control, and specific expertise in the design and implementation of QA documentation systems.

Charmaine Vercimak Sutton is an independent consultant to medical product manufacturers, providing services in product development, clinical design and management, quality system development and implementation and regulatory compliance to meet FDA expectations.

Together, DeSain and Sutton provide GMP regulatory consulting for drug, device, and biologics manufacturers through their Tofte, Minnesota-based company, The Tamarack Group.