Call us at +1-(510)-868-1040

Login Register

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.


  • 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
     


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.


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


Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices, including roles as Executive Business Consultant, Worldwide Director of Product Quality, and Director of Corporate Compliance. 

Sussane is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 is a CQA (Certified Quality Auditor) from the American Society for Quality. She has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. Her new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available at Elsevier and Amazon.

View all trainings by this speaker
 
Live Webinar

Live + Recorded Session

Get unlimited access to the link for one participant, from the date of webinar completion.

$269

Live + Transcript

Get unlimited access to the link for one participant, from the date of webinar completion.

$249

Live + Training CD

Free shipment within 3 to 5 Days from the date of webinar completion.

$450

On Demand

Transcript

PDF Transcript of the Training which are available once the webinar is completed.(Transcript for single user only)

$179

Downloadable recorded session

Get unlimited access to the link for six months.

$239

Training CD

Free shipment within 72 Hours, from the date of webinar completion

$350

Group Session

Group Session unlimited participants + Recorded

Live session for unlimited participants

$799

  

Upcoming Webinars