Practical Process Validation

Quality Press, 14 juil. 2016 - 168 pages

 For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards.

The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.


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Table des matières

Section 1
Section 2
Section 3
Section 4
Section 5
Section 6
Section 7
Section 8
Section 13
Section 14
Section 15
Section 16
Section 17
Section 18
Section 19
Section 20

Section 9
Section 10
Section 11
Section 12
Section 21
Section 22
Section 23
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