Quality Risk Management in the FDA-Regulat...

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Sprache: Englisch

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Beschreibung

"Risk-based thinking and processes are increasingly important for all organizations, including those regulated by the FDA. This book is an essential guide to a systematic and comprehensive approach to quality risk management. The revised content in this third edition offers an updated view of the risk management field as it applies to FDA-regulated products: how to integrate risk management principles and activities into an existing QMS, remain in compliance with ISO 9001:2015 and ISO 13485:2016, and integrate three key and recently updated guidelines [ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018]. Also includes practical explanations and plenty of helpful case studies and examples"-- Provided by publisher.

Details

Erscheinungsjahr:	2024
Genre:	Importe
Produktart:	Geschenkbücher
Rubrik:	Belletristik
Medium:	Taschenbuch
ISBN-13:	9781636941554
ISBN-10:	1636941559
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Autor:	Rodriguez-Perez, Jose (Pepe)
Auflage:	3. Auflage
Hersteller:	ASQ Quality Press
Verantwortliche Person für die EU:	Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße:	229 x 152 x 17 mm
Von/Mit:	Jose Rodriguez-Perez
Erscheinungsdatum:	31.12.2024
Gewicht:	0,455 kg