Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very 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 practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena. A companion CD-ROM contains dozens of FDA guidance documents and international harmonization documents (ICH and GHTF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

Quality Risk Management in the FDA-Regulated Industry

Business & Money

José Rodríguez-Pérez

Education & Reference

Quality Press

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. A companion CD contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for cGMP audit is also included based on risk management criteria. An exam complements the material included in the CD.

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Industries

Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include:
 ~Information about the importance of the CAPA system within the quality system for the medical products regulated industry. ~Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. ~Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. ~New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. ~A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. ~Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. ~An example of an investigation and CAPA expert certification program being used for many companies. ~Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format.
 While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.

Handbook of Investigation and Effective CAPA Systems, Second Edition

ASQ-Quality Press

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.

Quality Risk Management in the FDA-Regulated Industry, Second Edition

For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. 
 The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. 
 Written in a direct style, using simple industry language with abundant applied examples and practical references, this book s insights on human failure reduction will improve individual, organizational, and social well-being.

Human Error Reduction in Manufacturing

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

Data Integrity and Compliance: A Primer for Medical Product Manufacturers

Management & Leadership

Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects’ to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. 
Enhancements to the third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company • Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 • Updated inspectional observations from the U.S. FDA and U.K. MHRA • A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process • New charts and information related to the investigation of human errors; the human factor section includes information about training and competence • A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results • Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error

Handbook of Investigation and Effective CAPA Systems, Third Edition

The FDA & Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals(With CD-ROM)

ASQ/Infotech

CAPA for the FDA-Regulated Industry

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Books by José Rodríguez-Pérez