Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive quality culture. This course will also discuss the latest draft guidance from the FDA in regards to quality metrics.
Part 1 – Establishing appropriate quality metrics
Part 2 – Driving Quality Culture through appropriate Quality Metrics
Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics
Part 1 – Establishing Appropriate Quality Metrics
In this section, we will understand and discuss:
Part 2 – Driving Quality Culture through appropriate Quality Metrics
In this section, we will understand and discuss:
Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive quality culture, and the course will also discuss the latest draft guidance from the FDA in regards to quality metrics.
Susanne Manz 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. She 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.