Lesson Code: OPE-1101 (PREMIUM LESSON). An overview of the key concepts and terminologies associated with nonconformities, and the CAPA methodology used to address them as part of a company’s Quality System. Using a scenario-driven approach, the user is taken through the key steps of a CAPA process from identifying a problem to verifying the effectiveness of the solutions implemented to resolve it. In doing so, users will be better equipped to distinguish between corrections, corrective actions, and preventive actions. The concept of risk and categorization of nonconformities as minor, major, or critical is also covered as are regulatory expectations surrounding nonconformities and CAPA.