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 can also endanger patient safety, cost money, and steer internal focus away from other issues.
We’ve helped many companies assess the health of their CAPA systems and find that it often comes down to the basics: determining the need for CAPA and defining the problem. This course provides a deep dive into the process, beginning with a solid problem definition statement, which is determined with data that can be used to verify the effectiveness of the implemented solution. Using workshops, case studies, and simulations, in this course you’ll work through the entire root cause analysis process, from creating a data-based problem statement, applying RC tools, and conducting data analysis for verifying the cause to selecting the best solution and determining its effectiveness.