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Quality Risk Management in the FDA-Regulated Industry, by José Rodríguez-Pérez
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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.
- Sales Rank: #584305 in Books
- Published on: 2012-06-12
- Original language: English
- Dimensions: 9.00" h x 6.00" w x 1.00" l, 1.10 pounds
- Binding: Paperback
- 288 pages
Most helpful customer reviews
4 of 5 people found the following review helpful.
Best book for the topic
By Quality Engineer, Six Sigma black belt
If you are a professional working in the medical industry, I strongly recomend you this book.
It start from a very high level process description(QSR, ISO-standards, GHTF, Quality Management System),to an overview of the most used Risk management tools, to finish with very useful examples and case-studies.
I have found very interesting the description of the interaction between Risk and the different areas of the Quality Management system.
Pros:
- easy to read, very detailed
- it shows the trends in the current industry
Cons:
- missing information about the expectations from regulatory bodies other than USA (but this was the intention of the book)
In summary, a must to have book.
0 of 0 people found the following review helpful.
I recommend it.
By Martin Kvokacka
just started reading it and it helped to answer our questions within company. I recommend it.
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