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

DeSain, Carol

Hardcover

ISBN 10: 0929870395 ISBN 13: 9780929870397

Publisher: ADVANSTAR COMMUNICATIONS, 1996

Synopsis

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.

About this title

About the Author

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.

From the Back Cover

Documentation Practices demystifies the documentation process and provides an accurate and meaningful understanding of manual document management requirements. It includes comprehensive information about documents, documentation, document management, and document systems, and it features specific examples of Commitment Documents, Directive Documents, and Data Collection Documents. The knowledge this book provides will minimize the number of documents required to achieve compliance and will help in designing electronic documents, databases, and management systems in the future.

From the Inside Flap

Documentation Practices: A complete guide to document development and management for GMP and ISO 9000 compliant industries includes everything you ever needed, or wanted, to know about documents and document management systems. It provides an accurate and meaningful understanding of manual document management requirements; features complete coverage of documents, documentation, document management, and document systems; and includes specific examples of Commitment Documents, Directive Documents, and Data Collection Documents.

The information Documentation Practices provides will help the inexperienced reader understand the purpose of documents and documentation; will aide the experienced reader in designing new electronic documents, databases, and management systems; and will provide both with valuable insights when existing systems begin to fail.

Edition details

• Publisher: ADVANSTAR COMMUNICATIONS
• Publication date: 1996
• Language: English
• ISBN 10: 0929870395
• ISBN 13: 9780929870397
• Binding: Hardcover
• Edition number: 1
• Number of pages: 180