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:
How RCA fits into the CAPA process
Build the right team
Develop a problem statement
Essential tools for your RCA toolbox
How to Verify your Results
Real Lessons Learned
Do's and Don'ts of CAPA
Who Will Benefit:
CAPA Project Leaders
Supplier Quality Engineers
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.
She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Netzealous LLC, DBA -Compliance4all
Email: [email protected]