Non-Fiction Books:

GMP Audit Trainer

Good Manufacturing Practices Made Easy
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Paperback / softback
$91.00
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  • Around 1-11 July using International Courier

Description

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
Release date NZ
July 7th, 2017
Audience
  • General (US: Trade)
Pages
464
Dimensions
140x216x24
ISBN-13
9781548711931
Product ID
37399634

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