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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  This course will also discuss the latest draft guidance from the FDA in regard to Quality Metrics.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.


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.

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.

Discuss the 2016 Draft Guidance from the FDA on Quality Metrics

  • Review the contents of the FDA guidance on Quality Metrics.

This course will discuss the latest draft guidance from the FDA in regard to Quality Metrics.


  • Regulatory Affairs professionals
  • Quality Managers
  • Quality Engineers

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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Nov. 1, 2024

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

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