Corrective Action Preventive Action (CAPA)

This course covers the Corrective Action Preventive Action (CAPA) system — the tools used to identify the root cause of deviations, methods used for root cause analysis, the processes for corrective action, and remedial corrections of an identified problem. In addition to the lecture component, participants will review scenarios requiring CAPA and learn strategies for implementing the CAPA process, with the goal of averting recurrence of similar potential problems before they occur and ensuring they do not happen again.

Suggested audiences include biotech industry service providers and personnel involved in the manufacture and/or testing of pharmaceutical and biopharmaceutical products and devices. This includes (but is not limited to) personnel working in quality management, quality assurance, risk management, quality control, and document control as well as process development, assay development, and CGMP-compliant environments