Conference Description:

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.

Areas Covered in the Session :

>. 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 Should Attend:

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. The employees who will benefit include:

>. Senior Management
>. Middle Management
>. Quality Assurance Departments
>. Regulatory Affairs Departments
>. R&D Departments
>. Operations Departments
>. Production Departments
>. Manufacturing Departments
>. Engineering Departments