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.
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.
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.