As a significant and core system in the medical device quality system, an effective corrective and preventive action (CAPA) procedure is of great value in the quality system management. This two-day course will focus on how to develop and run a CAPA procedure.
Upon completion of this course, participants will have gained an understanding of the basic concepts involved in the CAPA procedure with an in-depth review of the agency's preamble, regulations, guidelines, inspection guides, compliance policy guides, 483s, and warning letters. Emphasis is placed on the practical aspects of how to perform the CAPA procedure including problem collection, investigations, handling of nonconforming products, formulating action plans, implementation and follow-up for actions, and documentation. Situation analyses and case studies are adopted to let participates practice the skills in simulated working operations.