GMP Audit Trainer: Good Manufacturing Practices Made Easy

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GMP Audit Trainer: Good Manufacturing Practices Made Easy

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
Country USA
Brand Createspace Independent Publishing Platform
Manufacturer CreateSpace Independent Publishing Platform
Binding Paperback
UnitCount 1
EANs 9781548711931
ReleaseDate 0000-00-00

Country	USA
Brand	Createspace Independent Publishing Platform
Manufacturer	CreateSpace Independent Publishing Platform
Binding	Paperback
UnitCount	1
EANs	9781548711931
ReleaseDate	0000-00-00

GMP Audit Trainer: Good Manufacturing Practices Made Easy

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