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 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. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. 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
- Marketing Departments
- Medical Device Consultants
- cGMP Instructors
- Everyone involved in product, process, CAPA resolution, failure investigation responsibilities
Course Director: JOHN E. LINCOLN
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.
He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.