CAPA for the FDA-Regulated Industry

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About this item

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.
ASIN: 0873897978
VSKU: DBV.0873897978.A
Condition: Acceptable
Author/Artist:Rodriguez-perez, Jose
Binding: Hardcover
Note: Any images shown are stock photographs and product may differ from what is shown.
Condition Notes: This copy has clearly been enjoyed—expect noticeable shelf wear and some minor creases to the cover. Binding is strong, and all pages are legible. May contain previous library markings or stamps.
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