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

Susanne Manz Instructor:
Susanne Manz 
Tuesday, August 23, 2022
10:00 AM PDT | 01:00 PM EDT
90 Minutes
Webinar ID: 500642

More Trainings by this Expert

Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

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 of experience. You will learn about the RCA toolbox and how to get a 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. 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.


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