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Pharmaceutical Engineering Change Control

Pharmaceutical Engineering Change Control

2nd edition

Paperback (23 Sep 2019)

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Publisher's Synopsis

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control training. It gives readers a toolbox for ensuring that adequate controls are implemented.

Book information

ISBN: 9780367394745
Publisher: CRC Press
Imprint: CRC Press
Pub date:
Edition: 2nd edition
DEWEY: 615.1900685
DEWEY edition: 22
Language: English
Number of pages: 200
Weight: 453g
Height: 234mm
Width: 156mm
Spine width: 13mm