Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

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 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 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.

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