ISBN: 9780873899482 - quality risk management in the fda-regulated industry (19 resultados)

Condición: very_good. Cover may have light wear, pages in very good condition and binding is sturdy; may have other light shelf wear or creases. May have notes or highlighting.

Condición: very_good. Gently read. May have name of previous ownership, or ex-library edition. Binding tight; spine straight and smooth, with no creasing; covers clean and crisp. Minimal signs of handling or shelving. 100% GUARANTEE! Shipped with delivery confirmation, if you're not satisfied with purchase please return item! Ships USPS Media Mail.…

Condición: New.

Hardback or Cased Book. Condición: New. Quality Risk Management in the FDA-Regulated Industry. Book.

Condición: As New. Unread book in perfect condition.

Condición: New.

Hardback. Condición: New. 2nd ed.

Condición: New.

Condición: As New. Unread book in perfect condition.

Hardcover. Condición: Brand New. second edition. 9.25x6.26x1.10 inches. In Stock.

Hardback. Condición: New. 2nd ed.

HRD. Condición: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

HRD. Condición: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

Hardback. Condición: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.

Condición: New. Print on Demand.

Condición: New. Print on Demand.

Condición: New. PRINT ON DEMAND.

Buch. Condición: 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.…

Buch. Condición: 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.…