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GMP Inspections: Basics for Beginners - Tapa blanda

Cooper, Mr Brendan

 
9781548715328: GMP Inspections: Basics for Beginners
Tapa blanda
ISBN 10: 1548715328 ISBN 13: 9781548715328
Editorial: CreateSpace Independent Publishing Platform, 2017

Sinopsis

At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnology). The opening chapter covers the basics- principles of GMP, how it applies to people, equipment, materials and processes. This is then followed with chapters outlining the key themes and areas that arise within the various industries or specialties. While many GMP requirements apply to all medical and medicinal products, some area's exhibit additional requirements and focus points when it comes to audits and GMP inspections. Each chapter is clear, concise and draws heavily on published guidance from the FDA and other regulatory bodies. This results in a well structured summary or road map that details key topics and technical points subject to inspection. The following chapters are included: Introduction to Good Manufacturing Practices, Preparation for Audits, Inspection of Quality Systems, During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Sterile Drugs Inspection Guide, Computerised Systems Inspection Guide and Cleaning Inspection Guide.

"Sinopsis" puede pertenecer a otra edición de este libro.

Reseña del editor

At over 400 pages, this book introduces the area of Good manufacturing and compliance for Regulated industries (Medical devices, pharmaceuticals and Biotechnology). The opening chapter covers the basics- principles of GMP, how it applies to people, equipment, materials and processes. This is then followed with chapters outlining the key themes and areas that arise within the various industries or specialties. While many GMP requirements apply to all medical and medicinal products, some area's exhibit additional requirements and focus points when it comes to audits and GMP inspections. Each chapter is clear, concise and draws heavily on published guidance from the FDA and other regulatory bodies. This results in a well structured summary or road map that details key topics and technical points subject to inspection. The following chapters are included: Introduction to Good Manufacturing Practices, Preparation for Audits, Inspection of Quality Systems, During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Sterile Drugs Inspection Guide, Computerised Systems Inspection Guide and Cleaning Inspection Guide.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
CreateSpace Independent Publishing Platform
Año de publicación
2017
Idioma
Inglés
ISBN 10 
1548715328
ISBN 13 
9781548715328
Encuadernación
Tapa blanda
Número de páginas
434
Contacto del fabricante
Manufactured by Amazon on behalf of the author
https://www.amazon.es/hz/contact-us

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