Essentials of Root Cause Analysis for CAPA
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has worked at industry-leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 is a CQA (Certified Quality Auditor) 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.
Susanne is the author of Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, available on Elsevier and Amazon.
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.
Areas Covered
This 90-minute webinar will focus on how to conduct efficient and effective root cause analysis.
- How RCA fits into the CAPA process
- Build the right team
- Develop a problem statement
- Failure Investigation
- Data Collection
- Analysis techniques
- Essential tools for your RCA toolbox
- How to Verify your Results
- Real Lessons Learned
- Do’s and Don’ts of CAPA
- Best Practices
- Inspection Readiness
Who Should Attend
- Quality Engineers
- Manufacturing Engineers
- Process Engineers
- Compliance Specialists
- Auditors
- CAPA Specialists
- CAPA Project Leaders
- CAPA Managers
- Supplier Quality Engineers
Why Should You 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 a permanent resolution to your significant quality problems.
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$200.00
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