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

By attending this webinar you will learn about the RCA toolbox and how to get permanent resolution to your significant quality problems, also learn how to analyze and document the root cause of the problem, Learn best practices for handling complaints.

Susanne Manz
Instructor:
Susanne Manz
Date:
Wednesday, January 15, 2020
Time:
10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502836

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
Price Detail Options
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. 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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