Slides on CAPA systems, presented at BosCon 2009, are available in the Ombu Library

Dan O’Leary presented a talk at BosCon 2009 on CAPA systems. The presentation explains the requirements in ISO 9001, ISO 13485, and the FDA QSR, cutting through the confusion often associated with Preventive Action, Correction, and Corrective Action. Building on this clear understanding, the presentation explains how to design and implement effective systems and develops metrics for effectiveness and efficiency. We also explore the relationship that CAPA system has to other systems in the regulations including corrections and removals and management review.