Pharmaceutical Engineering Change Control - Softcover

Softcover

ISBN 10: 036739474X ISBN 13: 9780367394745

Publisher: CRC Press, 2019

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.

About this title

About the Author

Simon G. Turner

From the Back Cover

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.

Edition details

• Publisher: CRC Press
• Publication date: 2019
• Language: English
• ISBN 10: 036739474X
• ISBN 13: 9780367394745
• Binding: Paperback
• Edition number: 2
• Number of pages: 200
• Editor: Turner Simon G.