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.
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.
Speaker
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.
Who Should Attend
- Quality Engineers
- Manufacturing Engineers
- Process Engineers
- Compliance Specialists
- Auditors
- CAPA Specialists
- CAPA Project Leaders
- CAPA Managers
- Supplier Quality Engineers
