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

By: Susanne Manz
Recorded Session
Duration
90 Minutes
Training Level
Intermediate to Advanced

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Recorded Session

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Webinar Details

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.

LEARNING OBJECTIVES

  • Build the right team
  • Develop a problem statement
  • Failure Investigation
  • Data Collection
  • Analysis Tools and Techniques
  • How tVerify 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
     

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.

  • Build the right team
  • Develop a problem statement
  • Failure Investigation
  • Data Collection
  • Analysis Tools and Techniques
  • How tVerify your Results
  • Real Lessons Learned
  • Do’s and Don’ts of CAPA
  • Best Practices
  • Inspection Readiness
     
  • Quality Engineers
  • Manufacturing Engineers
  • Process Engineers
  • Compliance Specialists
  • Auditors
  • CAPA Specialists
  • CAPA Project Leaders
  • CAPA Managers
     

SPEAKER PROFILE

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.