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

Susanne Manz
Instructor: Susanne Manz
Date: Wednesday November 27, 2024
Time:

10:00 AM PST | 01:00 PM EST

Duration: 90 Minutes
Webinar Id: 606051

Price Details

Live Webinar
$150. One Attendee
$290. Unlimited Attendees
Recorded Webinar
$190. One Attendee
$390. Unlimited Attendees
Combo Offers   (Live + Recorded)
$289 $340   One Attendee
$599 $680   Unlimited Attendees

Unlimited Attendees: Any number of participants

Recorded Version: 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 you should 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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