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Hardcover. Zustand: Good. Second. Ships in a BOX from Central Missouri! May not include working access code. Will not include dust jacket. Has used sticker(s) and some writing or highlighting. UPS shipping for most packages, (Priority Mail for AK/HI/APO/PO Boxes).
Zustand: New.
Sprache: Englisch
Verlag: ASQ Quality Press 2/21/2017, 2017
ISBN 10: 0873899482 ISBN 13: 9780873899482
Anbieter: BargainBookStores, Grand Rapids, MI, USA
Hardback or Cased Book. Zustand: New. Quality Risk Management in the FDA-Regulated Industry. Book.
Anbieter: California Books, Miami, FL, USA
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Anbieter: GreatBookPricesUK, Woodford Green, Vereinigtes Königreich
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In den WarenkorbZustand: good. May show signs of wear, highlighting, writing, and previous use. This item may be a former library book with typical markings. No guarantee on products that contain supplements Your satisfaction is 100% guaranteed. Twenty-five year bookseller with shipments to over fifty million happy customers.
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In den WarenkorbHardcover. Zustand: Brand New. second edition. 9.25x6.26x1.10 inches. In Stock.
Sprache: Englisch
Verlag: American Society for Quality Press, 2017
ISBN 10: 0873899482 ISBN 13: 9780873899482
Anbieter: PBShop.store US, Wood Dale, IL, USA
HRD. Zustand: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
Sprache: Englisch
Verlag: American Society for Quality Press, 2017
ISBN 10: 0873899482 ISBN 13: 9780873899482
Anbieter: PBShop.store UK, Fairford, GLOS, Vereinigtes Königreich
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In den WarenkorbHardback. Zustand: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
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Buch. Zustand: Neu. Quality Risk Management in the FDA-Regulated Industry | José Rodríguez-Pérez | Buch | Englisch | 2017 | ASQ Quality Press | EAN 9780873899482 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand.
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Buch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years.This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice.All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.