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Quality Systems and Gmp Regulations for Device Manufacturers: A Practical Guide to U.S., European, and Iso Requirements - Couverture rigide

Kuwahara, Steven S.

 
9780873894265: Quality Systems and Gmp Regulations for Device Manufacturers: A Practical Guide to U.S., European, and Iso Requirements
Couverture rigide
ISBN 10 : 087389426X ISBN 13 : 9780873894265
Editeur : ASQC/Quality Press, 1998

Synopsis

This book provides a single roadmap for compliance with the US QSR, the European Medical Device Directives, and ISO Standards for device and diagnostic products. Written in case-study format, it begins with information on how to establish a QSR documentation system. Dr. Kuwahara explains implementation methods for each section of the QSRs (21 CFR 820). Documentation requirements and guidelines for what documentation you need for your quality system, why you need it, and how to prepare it are detailed, as well as practical information on efficiently and effectively organizing your records, procedures, work instructions, and Quality Manual. The book shows you how to evaluate your existing documentation's fit with the worldwide quality systems and the GMPs/QSRs. A grid comparing ISO 9001 and US 21 CFR 820 requirements is included.

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

Présentation de l'éditeur

This book provides a single roadmap for compliance with the US QSR, the European Medical Device Directives, and ISO Standards for device and diagnostic products. Written in case-study format, it begins with information on how to establish a QSR documentation system. Dr. Kuwahara explains implementation methods for each section of the QSRs (21 CFR 820). Documentation requirements and guidelines for what documentation you need for your quality system, why you need it, and how to prepare it are detailed, as well as practical information on efficiently and effectively organizing your records, procedures, work instructions, and Quality Manual. The book shows you how to evaluate your existing documentation's fit with the worldwide quality systems and the GMPs/QSRs. A grid comparing ISO 9001 and US 21 CFR 820 requirements is included.

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

Éditeur
ASQC/Quality Press
Date d'édition
1998
Langue
anglais
ISBN 10 
087389426X
ISBN 13 
9780873894265
Reliure
Relié
Nombre de pages
236
Coordonnées du fabricant
non disponible
Personne responsable
non disponible