Failure Investigations (FI) and Root Cause Analysis (RCA) are vital elements of a robust, “bullet-proof”, “closed-loop” Corrective and Preventive Action (CAPA) program, often required in product or equipment validations. Rigorous FI and RCA show a company’s Quality Management System to be proactive, and result in meeting / exceeding cGMP requirements and U.S. FDA expectations. Meaningful FI / RCA requires a specific sequence of activities, each building on the other, to eliminate non-conformances, out-of-specification conditions, improve product quality, and most importantly, to enhance patient safety.
It is key to many all important cGMP activities – CAPA, P&PC (Production and Process Control), non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and work flow are not understood, disseminated, and used, consistently. Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events. Avoid a “shoot from the hip” approach. Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of any “closed-loop” non-conformance resolution system.
Areas to be Covered:
Robust non-conformance resolution system requirements
Understanding Failure Investigation and Root Cause Analysis
The U.S. FDA Expectations
Understanding “Closed Loop” CAPA
Failure Investigation / Analysis Methodology using a suggested Template
Powerful Tools for Root Cause Analysis
Determining and Monitoring for Effectiveness
Verification and validation (V&V)
Take It to the Next Level
Who will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to review and modify their company’s FI / RCA, and V&V / CAPA system. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
QA / RA
All personnel involved in product, process, CAPA resolution, failure investigation responsibilities