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

CAPA is the cornerstone of quality improvement, and it only works when the root cause analysis behind it is sound. This 90-minute root cause analysis for CAPA training covers what makes an RCA effective, along with FDA expectations and tips for conducting and documenting the work.

You'll learn how to build the right team, write a problem statement, carry out a failure investigation and collect data, then apply analysis tools and techniques from the RCA toolbox and verify your results.

The session also discusses common myths and challenges, real lessons learned, the do's and don'ts of CAPA, best practices and inspection readiness.

• Explain FDA expectations for root cause analysis in CAPA
• Build an effective RCA team and problem statement
• Conduct a failure investigation and collect the right data
• Use RCA tools and techniques to find root causes
• Verify that your corrective actions worked
• Apply CAPA best practices and prepare for inspections

• FDA expectations for root cause analysis
• Myths and challenges of root cause analysis
• Building the right team
• Developing a problem statement
• Failure investigation
• Data collection
• Analysis tools and techniques
• Verifying your results
• Real lessons learned
• Do's and don'ts of CAPA
• Best practices
• Inspection readiness

Root cause analysis can feel daunting, and without it a CAPA won't deliver the improvement you need, wasting time and money. This session shares practical lessons for reaching a permanent fix for significant quality problems.

It suits quality, manufacturing and process engineers, compliance specialists, auditors, and CAPA specialists, project leaders and managers.

• Quality Engineers
• Manufacturing Engineers
• Process Engineers
• Compliance Specialists
• Auditors
• CAPA Specialists
• CAPA Project Leaders
• CAPA Managers
   

Susanne Manz 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. She 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.