Medical Device CAPA and Root Cause Investigation Training
Every RA/QA manager has struggled with repeat CAPAs. A problem you thought had been solved pops up again months later, but why? Persistent problems are not only annoying, they endanger patient safety, cost money, and redirect focus from other issues. Using workshops, case studies, and simulations, you'll learn how to use Corrective and Preventive Action (CAPA) as a program to correct and prevent product and quality problems, as well as root cause analysis as a methodology for finding the cause of product and quality problems. This course covers CAPA requirements from ISO 13485:2016 and US FDA, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.