Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
September 18, 2020 - CA USCompliance4All
support@compliance4All.com
Phone:8004479407
Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation. Why you should Attend: CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. You will waste precious time and money and still end up with unsatisfactory results. This webinar will give you insights and lessons learned from a certified Master Black Belt and industry expert with over 30 years' experience. You will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems. Areas Covered in the Session: Build the right team Develop a problem statement Failure Investigation Data Collection Analysis Tools and Techniques How to Verify your Results Real Lessons Learned Do's and Don'ts of CAPA Best Practices Inspection Readiness Who Will Benefit: Quality Engineers Manufacturing Engineers Process Engineers Compliance Specialists Auditors CAPA Specialists CAPA Project Leaders CAPA Managers Speaker Profile Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.