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8th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

Philadelphia, USA

Joe Helmstetler

Joe Helmstetler

Rhizo Sciences, USA

Title: Investigations, root cause analysis, corrective & preventive actions and why “human error” is not the true root of the problem

Biography

Biography: Joe Helmstetler

Abstract

Proper Root Cause Analysis (RCA) is essential to ensure the implementation of Corrective & Preventive Actions (CAPA). A poorly executed RCA can lead to incorrect and ineffective CAPAs, which leads to repeated failures. Any event requiring RCA and CAPA is an opportunity for improvement, not only related to the original event but also in relation to any quality or compliance issues discovered during the investigation. Some estimates state that 80% of adverse events are due to human error. This could not be further from the truth. Commonly, root causes that are attributed to human error are incomplete investigations/RCAs as one must go beyond human error to discover the true root cause.