Pharmaceutical Engineering Change Control

Herausgeber: Turner, Simon G

• Broschiertes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• 2nd edition
• Seitenzahl: 200
• Erscheinungstermin: 23. September 2019
• Englisch
• Abmessung: 231mm x 155mm x 13mm
• Gewicht: 91g
• ISBN-13: 9780367394745
• ISBN-10: 036739474X
• Artikelnr.: 57815454

Autorenporträt

Simon G. Turner

Inhaltsangabe

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.