New Biotility Course – Root Cause Analysis

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The regulatory requirements outlined in U.S. Food and Drug Administration (FDA) regulations (21 CFR 210 & 211) require Current Good Manufacturing Practices (cGMP) compliant organizations to have a formal quality system in place to investigate nonconformances. By conducting a thorough investigation, the organization reduces waste, improves process, and ensures an understanding of why the event occurred and how to properly mitigate the impact.

This course provides an overview of performing a root cause analysis for nonconformances in manufacturing environments. It summarizes the critical components of an investigation framework using root cause analysis, including what data is important to collect and how it should be evaluated to determine impact to systems and controls. The course reviews different tools and methodologies that can be employed such as an initial triage, brainstorming, the five whys, and fishbone diagrams. It also explains the benefits of Corrective Action and Preventive Actions (CAPA) and the importance of monitoring CAPAs for effectiveness.



Individuals working in cGMP-compliant environments


Meet the Author

Brian Gandy, MA, LSSBB – National Resilience, Inc.