In case of non-compliance that could significantly affect patient safety or data quality, a Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) needs to occur to ensure the issue is appropriately corrected and prevented from happening again. We will introduce you to the different RCA techniques for a qualitative detection of root causes and how to link them to the most appropriate CAPA for the issue at hand.
At the end, you will receive a certificate and handy hand-outs for later use.
By the end of this TRIUM Training you should be able to:
- Define RCA and CAPA
- Describe the different RCA and CAPA methodologies
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.