Benefits:

• Understand the differences between the new FDA requirements and the 1978 FDA requirements.Save time by using the comparison chart rather than referring to separate documents.

Contents:

• General Provisions
• Quality System Requirements
• Design Controls
• Document Controls
• Purchasing Controls
• Identification and Traceability
• Production and Process Controls
• Acceptance Activities
• Nonconforming Product
• Corrective and Preventive Action
• Labeling and Packaging Control
• Handling, Storage, Distribution, and Installation
• Records
• Servicing
• Statistical Techniques
• Comparison Chart

Average Customer Rating: (5 of 5 based on 2 reviews)

• "This book has become a "bible" to our organization. The layout is very well done. FDA, ISO and the harmonization task force requirements, along with the FDA guidance, are placed together for easy reference and clarity. A fantastic reference guide."

  – Susan Hamann, Massachusetts

	Rate this Product
	Considering this book for your class?

210 pages. ISBN 978-0-87389-377-0. 6 x 9. Hardcover. 1996

Item: H0965
Member Price: $50.00
List/Forum-Division Price: $50.00

• The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
• The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
• Measurement Matters
• Safe and Sound Software (e-Book)
• The Certified HACCP Auditor Handbook

Requests for multiple subscriptions should be directed to ASQ Customer Care at 800-248-1946 or 414-272-8575.