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Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics
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. Metrics for numerous departmental functional areas will be discussed; including the associated mathematical equations. Additional, dashboards will be reviewed to give several options for how to display metric tracking to the organization and senior management. This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they 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. Attendees will have a complete understanding of how to calculate performance metrics; as well as, how to visually display those results to ensure those results are driving performance.
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, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.