Name: Gmp Audit Trainer: Good Manufacturing Practices Made Easy (en Inglés)
Price: 181530.00 COP
Availability: InStock
Author: Mr Brendan Cooper
ISBN: 9781548711931

portada Gmp Audit Trainer: Good Manufacturing Practices Made Easy (en Inglés)

Formato

Libro Físico

Editorial

Createspace Independent Publishing Platform

Autor

Mr Brendan Cooper

Idioma

Inglés

N° páginas

463

Encuadernación

Tapa Blanda

ISBN13

9781548711931

Gmp Audit Trainer: Good Manufacturing Practices Made Easy (en Inglés)

Mr Brendan Cooper (Autor) · Createspace Independent Publishing Platform · Tapa Blanda

Libro Físico

$ 181.530

$ 279.277

Ahorras: $ 97.747

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Origen: Estados Unidos (Costos de importación incluídos en el precio)

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Reseña del libro "Gmp Audit Trainer: Good Manufacturing Practices Made Easy (en Inglés)"

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