دانلود کتاب مدیریت ریسک کیفیت در صنعت تحت نظارت FDA

Since the publication of the first edition of this book in 2012, the emphasis on risk-based processes has grown exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001, the fundamental international quality management system (QMS) standard, was recently revised under the new version, ISO 9001:2015 (International Organization for Standardization 2015), and it now requires that top management promote the use of riskbased thinking. Another example of the greater emphasis on risk management is the international standard ISO 13485:2016, which specifies the requirements for a QMS specific to the medical device industry. The new version published in March 2016 (International Organization for Standardization 2016) shows a greater emphasis on risk management and risk-based decision-making. A third example is the U.S. FDA Food Safety Modernization Act (FSMA), the most important reform of U.S. food safety laws in more than 70 years. It was signed into law by President Obama on January 4, 2011. It aims to ensure that the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. In other words, it is a riskbased food safety prevention system. The purpose of this third edition of this book is to offer an updated view of the risk management field as it applies to FDA-regulated products. Three key guidelines have been recently updated [ICH Q9(R1), ISO 14971:2019, and ISO 22000:2018], and they are discussed in this new edition. This book will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing QMS 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. The first chapter of the book presents the historical background of the risk-based concepts and how the initial safety-only focus moved to a wider scenario with the consideration of several other elements. The second chapter presents what is currently being done in the different areas regulated by the FDA. It describes the updated harmonization documents and international standards developed for different types of products such as medical devices, food, and drugs. This chapter now includes the risk requirement of the newest version of ISO 14971:2019 for medical devices, the updated ICH guidance for industry Q9(R1) published in May 2023, and the new version of ISO 22000:2018 with its updated requirements for food safety management systems. A new section was included to discuss the latest initiative implemented by the FDA to use risk management plans to mitigate the potential of drug shortages. The third chapter describes the main principles of the quality risk management field, emphasizing the sound scientific basis of the quality risk management process and its close relationship with quality system elements. The fourth chapter details the quality risk management process, defining responsibilities and then, sequentially, the whole process, starting with risk assessment, continuing with risk control and risk communication, and ending with a review and evaluation of the effectiveness of the risk process. The fifth chapter describes the integration between risk management and quality management, including detailed examples of such integration. It also included a section covering pre- and post-market risk for medical products. The sixth chapter presents a collection of the methodologies and tools more widely used during risk management processes. Each tool is explained in great detail, including real examples from the FDA-regulated industry. These examples make this one of the most valuable sections of this book, along with the very detailed explanation and examples of practical applications that can be found in Chapter 7, including topics such as error risk reduction, benefit–risk determination, and data integrity issues. The eighth chapter discusses some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of failure mode and effects analysis (FMEA) as the only element of risk management programs.