Pharmaceutical Engineering Change Control

Buch | Softcover

200 Seiten

2019 | 2nd edition
CRC Press (Verlag)
978-0-367-39474-5 (ISBN)

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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.

Simon G. Turner

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.

Erscheinungsdatum	25.09.2019
Verlagsort	London
Sprache	englisch
Maße	156 x 234 mm
Gewicht	453 g
Themenwelt	Medizin / Pharmazie ► Pharmazie
	Naturwissenschaften ► Biologie
	Naturwissenschaften ► Chemie ► Technische Chemie
	Technik ► Umwelttechnik / Biotechnologie
ISBN-10	0-367-39474-X / 036739474X
ISBN-13	978-0-367-39474-5 / 9780367394745
Zustand	Neuware