Root-cause Analysis

Root cause analysis (RCA) is a systematic process for identifying “root causes” of problems or events. A Corrective and Preventative Action (CAPA) Plan is an approach for resolving those root causes and strategies to prevent those problems from recurring. These processes are mandatory for responding for an audit report by the Sponsor. However, it is recommended to adopt these approaches to address any problems that may arise during the clinical trial.

Contents

The Root-cause Analysis and Corrective and Preventative Action Plan short course provides students the principles and knowledge essential to conduct root-cause analysis and create a corrective and preventative action plan for an audit response report following a regulatory or sponsor quality audit/inspection.