FDA, Good Manufacturing Practices GMP, quality system, QSR, ISO 13485, regulatory consultants, manufacturing development device, drug, diagnostic, combination medical products, 510k, PMA, IDE
book, protocols, reports, master plan, method, process, product, development, qualification, installation, operational, good manufacturing practices, examples, documents Validation for Device and Diagnostic Manufacturers
second edition

by Carol DeSain and Charmaine Vercimak Sutton
Interpharm Press -1996

The information in this book is essential reading for every medical device o diagnostic employee involved in validation planning and strategies. It clearly answers your questions about the validation plan/protocol design and implementation process. A complete, step-by-step, how-to book that concentrates on implementation, it explains alternative actions to take when changes are observed or proposed for validated product designs, manufacturing processes, or test/inspection methods. This book saves you time, over and over again, as you maneuver through the validation changes of 21 CFR 820.30.

Table of Contents
Chapter 1: Introduction to Quality Systems
Chapter 2: Validation Overview
Chapter 3: Product Development and Validation
Chapter 4: Validation Study Documents: Master Plans, Protocols, Reports
Chapter 5: Process Development and Validation
Chapter 6: Test Method Development and Validation
Chapter 7: Qualification of Equipment and Equipment Systems
Chapter 8: Qualification of Software-Driven, Automated Equipment and Equipment Systems
Chapter 9: Facility Qualification Studies
Chapter 10: Validation Studies at Suppliers and Contractors
Chapter 11: Change Management for Validated Products, Processes and Methods
Chapter 12: Revalidation and Requalification Studies

Soft cover book - $192.00: To Order
Electronic copy - $179.96 - (PDF): To Order

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