3-Hour Virtual Seminar on Root Cause Analysis for CAPA Investigations

To ensure an organization’s quality system has a system to identify product and quality issues; the FDA mandates establishing a process for Corrective and Preventive Action. Any effective CAPA system must include the identification, documentation and review of root causes of problems. Systematic approaches for problem solutions need not only identify but also validate the effectiveness of a CAPA action. If both problem and deviation solutions handled individually; the frequent result is root causes are not identified and the problems reoccur. If you want to successfully maintain and improve pharmaceutical and biotech processes problem solving is a critical necessity. CAPA must be part of the company’s comprehensive quality management system (QMS). Processes are dynamic and as predicted by the 2nd law of thermodynamics will deteriorate over time if left alone.