Articles liés à GMP Audit Trainer: Good Manufacturing Practices Made...

GMP Audit Trainer: Good Manufacturing Practices Made Easy - Couverture souple

Cooper, Mr Brendan

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

Synopsis

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

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

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 AuditsInspection of Quality Systems During the InspectionBiotechnology Inspection GuideMedical Device Inspection GuideDrugs Inspection Guide Computerised Systems Inspection GuideCHAPTER 8Computerised Systems Inspection GuideIntroduction94Hardware 94Validation of Hardware96Software98Electronic Records and Signatures106Electronic Records Verification Methods117

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
CreateSpace Independent Publishing Platform
Date d'édition
2017
Langue
anglais
ISBN 10 
1548711934
ISBN 13 
9781548711931
Reliure
Broché
Nombre de pages
463
Coordonnées du fabricant
Manufactured by Amazon on behalf of the author
https://www.amazon.fr/hz/contact-us

c/o Amazon Media EU S.à.r.l., 38 Avenue John F. Kennedy
Luxembourg
L-1855
Luxembourg