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GMP Audit Trainer: Good Manufacturing Practices Made Easy - Softcover

Cooper, Mr Brendan

 
9781548711931: GMP Audit Trainer: Good Manufacturing Practices Made Easy
Softcover
ISBN 10: 1548711934 ISBN 13: 9781548711931
Verlag: CreateSpace Independent Publishing Platform, 2017

Inhaltsangabe

Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical industries. Achieving a successful audit outcome is essential to maintaining an effective QMS and fundamental to retaining manufacturing licenses. In order to align systems and processes to ensure compliance and favorable audit outcomes personnel must understand the auditor focus and methodologies. This book summarises key areas that inspections cover along typical areas of risk and concern. The following chapters are included:Introduction to Good Manufacturing Preparation for Audits Inspection of Quality Systems During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Drugs Inspection Guide, Computerised Systems Inspection Guide, Validation of Hardware and Software, Electronic Records and Signatures Electronic Records Verification Methods

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Verlag
CreateSpace Independent Publishing Platform
Erscheinungsdatum
2017
Sprache
Englisch
ISBN 10 
1548711934
ISBN 13 
9781548711931
Einband
Taschenbuch
Anzahl der Seiten
463
Kontakt zum Hersteller
Printed by Amazon on behalf of the author
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