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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 This course will also discuss the latest draft guidance from the FDA in regards to quality metrics.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

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Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics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

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. Another important aspect of this webinar will be to study the efficiency that comes along with the quality metrics and its easy implementation. FDA guidance on quality metrics is usually big a deal for any kind of organization, be it is individually owned or if it has wide operations. This is because it encapsulates highly legal obligations and perspective that is needed to be taken care of while operating and implementing Quality metrics on your organization. This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.

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

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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