Pharmaceutical Engineering Change Control (Paperback) (ISBN-13: 9780367394745)

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. The author 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 and customization of the change process to each project's needs. Case histories and anecdotes illustrate key points and provide a basis for change control training. The book gives readers a toolbox for ensuring that adequate controls are implemented.

Author: Simon G. Turner
ISBN-10: 036739474X
ISBN-13: 9780367394745
Publisher: CRC Press
Language: English
Published: 09/23/2019
Pages: 200
Format: Paperback
Weight: 0.20lbs
Size: 9.10h x 6.10w x 0.50d