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Title: Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to US, European, and ISO Requirements by Steven S. Kuwahara ISBN: 0-87389-426-X Publisher: Interpharm Press Pub. Date: 31 March, 1998 Format: Hardcover Volumes: 1 List Price(USD): $56.00 |
Average Customer Rating: 4 (1 review)
Rating: 4
Summary: Excellent book for those needing to meet GMP requirements.
Comment: This book provides extensive information for specialists in companies that have to comply with FDA regulations. It also has some good information on auditing that will be useful to quality engineers and auditors with limited experience in International Organization for Standardization (ISO), Food and Drug Administration (FDA), Code of Federal Regulations (CFR) and Good Manufacturing Practices (GMP) requirements. CFR standards are tough. Compliance with them, following the lead of this book, should help a company comply with the ISO standards. Companies that comply with the ISO standards, however, might not comply with the CFR requirements This book leads the reader through a series of steps that will help the company meet CFR requirements. It goes into extensive detail identifying and interpreting the various CFRs so that the readers will not take them too lightly. Some CFRs are much too vague and can lull newcomers to the field into thinking that they are in compliance when they are not. I would have rated this book as a 5 except that only a limited number of quality practitioners have a need for this material on GMP compliance. Hank Lefevre, CQE & PE
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Title: The Fda and Worldwide Quality System Requirements Guidebook for Medical Devices by Kimberly A. Trautman ISBN: 0873893778 Publisher: American Society for Quality Pub. Date: October, 1996 List Price(USD): $55.00 |
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Title: The CE Mark: Understanding the Medical Device Directive by Jan D. Coenraads, Brenda Van Broekhoven, Schaap Hartmann, Hugo Tander, Maud Veldkamp, Les Schnoll ISBN: 096504453X Publisher: Paton Press Pub. Date: 01 August, 1997 List Price(USD): $29.95 |
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Title: Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration by Gordon Harnack ISBN: 0873894553 Publisher: American Society for Quality Pub. Date: March, 1999 List Price(USD): $49.00 |
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Title: ISO 13485 (EN 46000) Requirements, 99 Requirements Checklist and Compliance Guide by Jack Kanholm, Lynette Howard ISBN: 1882711157 Publisher: AQA Press Pub. Date: 01 July, 1998 List Price(USD): $59.00 |
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