CAPA for the FDA-Regulated Industry

José Rodríguez-Pérez

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PDF  168 Pages    2011
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Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions. The corrective and preventive action system is known as the CAPA system. It is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems. This guidance book provides useful and up-to-date information about this critical topic to thousands of engineers, scientists, and manufacturing and quality personnel across the life sciences industries.

Understanding and improving the CAPA system as a whole is the focal point of this book, the first of its kind dealing exclusively with this critical system within this highly regulated industry. By helping those in this industry improve their CAPA systems, it will be a crucial aid in their mission of producing safe and effective products.



COMMENTS FROM OTHER CUSTOMERS

Average Customer Rating:image (5 of 5 based on 1 review)

"An excellent work presented that benefits the reader with a combination of CAPA knowledge and hands on experience rarely found on other publications…Any reader new to the CAPA process will end up with a good understanding of what CAPA is all about, presented in the right perspective and with the core information necessary to have a solid base to move around the CAPA environment in an effective compliant manner…During my years as a quality professional I have read many good books but only a few of those have been like a juice concentrate where you get a lot in a small package…A must to read for all regulated industry professionals "

  • A reader in Cayey, Puerto Rico

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