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| ASQ acaba de anunciar que el libro CAPA FOR THE FDA-REGULATED INDUSTRY se publicará durante el próximo mes de octubre. Después de muchos meses de arduo trabajo, por fin estará disponible para todos los profesionales de la industria regulada. El objetivo principal de este trabajo es convertirlo en una fuente de referencia asequible y al vez profunda sobre este tema tan importante para toda la industria. A continuación encontrareis el enlace con la página de ASQ donde se puede preordenar/comprar el mismo, así como la información que se provee allí. http://www.asq.org/quality-press/display-item/index.html?item=H1398 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. | Agosto 25, 2010 |
