Duration: 90 Minutes


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Instituting the right Quality Assurance metrics is significant for numerous reasons. The health of your quality system can be measured using these metrics, which not only helps in changing course but also aids in driving a quality culture, which in turn improves individual and Company performance. 

During the webinar, we will be highlighting the necessity of establishing metrics, how to differentiate Key Performance Indicators (KPIs) and also how metrics help to create a Quality Culture. 

We will also be covering the latest draft guidance from the FDA with regards to Quality Metrics.

Areas Covered in the Session :

Part 1 – Establishing Appropriate Quality Metrics

  • Understand why metrics are important to both individuals and management
  • Understand the difference between Key Performance Indicators (KPIs) and metrics
  • Review common Quality metrics and the associated mathematical equations
  • Discuss the use of dashboards
  • Discuss common errors associated with establishing metrics

Part 2 – Driving Quality Culture through appropriate Quality Metrics

  • Understand that what gets measured will directly impact employee behaviors
  • Discuss how to ensure Quality metrics will result in the behaviors you want
  • Discuss how to utilize Quality metrics to improve both individual and company performance

Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics

  • Review the contents of the FDA guidance on Quality Metrics

Who Should Attend:

  • Research and Development Departments
  • Quality Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Regulatory Affairs Departments

Course Director: SUSANNE MANZ ‎

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.