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CAPA in the Medical Device Industry
Level of Difficulty
Beginner (no knowledge at all of the topic).
Corrective and Preventive Action (CAPA) continues to be one of the top two causes of 483s from the FDA. One of the main causes of companies receiving a CAPA 483 from the FDA is failure by the company to fully understand the FDA’s expectations of a well run CAPA system. This course provides delegates with a comprehensive understanding of the FDAs expectations while also explaining the European requirements for CAPA.
By attending this course delegates will obtain the tools and skills necessary to implement a CAPA system that not alone meets FDA and European requirements, but also brings about real improvement in the company’s product and Quality System performance. Practical exercises will be completed throughout the day covering real life situations so that delegates can be confident of implementing CAPA requirements to the FDA’s satisfaction when they return to the workplace.
The course covers the Seven CAPA Steps approach to fulfilling the CAPA related requirements of 21 CFR part 820, 21 CFR Part 211, ISO 13485, ICH Q10 and, FDA and European Guidance Documents.