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.
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Quality Risk Management in the FDARegulated Industry
Also available from ASQ Quality Press:
Handbook of Investigation and Effective CAPA Systems, Second Edition José Rodríguez-Pérez The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals José Rodríguez-Pérez Statistical Process Control for the FDA-Regulated Industry Manuel E. Peña-Rodríguez Proactive Supplier Management in the Medical Device Industry James B. Shore and John A. Freije The ISO 9001:2015 Implementation Handbook: Using the Process Approach to Build a Quality Management System Milton P. Dentch The Certified Six Sigma Yellow Belt Handbook Govindarajan Ramu The Certified Pharmaceutical GMP Professional Handbook, Second Edition FDC Division and Mark Allen Durivage, editor Process Improvement Simplified: A How-To Book for Success in any Organization James B. King, Francis G. King, and Michael W. R. Davis Failure Mode and Effect Analysis: FMEA from Theory to Execution, Second Edition D. H. Stamatis The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing J. B. Smith Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement, and Data Analysis Lance B. Coleman Mastering and Managing the FDA Maze, Second Edition Gordon Harnack Development of FDA-Regulated Medical Products, Second Edition Elaine Whitmore
To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at www.asq.org/quality-press.
Quality Risk Management in the FDARegulated Industry
Library of Congress CataloginginPublication Data
Library of Congress Cataloging in Publication Control Number: 2016058370
Names: Rodríguez Pérez, José, 1961– author. Title: Quality risk management in the FDA-regulated industry / Jose Rodriguez-Perez. Description: Second edition. | Milwaukee, Wisconsin : ASQ Quality Press, [2017] | Includes bibliographical references and index. Identifiers: LCCN 2016058370 | ISBN 9780873899482 (hard cover : alk. paper) Subjects: LCSH: Pharmaceutical industry—Government policy—United States. | Food industry and trade—Government policy—United States. | Risk management—United States. | Total quality management—United States. Classification: LCC HD9666.6 .R637 2017 | DDC 615.1068/4—dc23 LC record available at https://lccn.loc.gov/2016058370
ISBN: 978-0-87389-948-2
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