Online Webinar 2019 - Live Webinar 90 minutes Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Overview
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. This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.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.
This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.
Session Highlights
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Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics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 Will Benefit
All Regulatory Affairs Personnel
Quality Managers
Quality Engineers
Clinical Research Associates
Investigators
Clinical Project Managers
Medical Writers
Speaker
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.