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 This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.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This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.

Webinar Takeaway

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Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics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

Kelly Thomas (25+ year exp.)

Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA

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.

Choose a Purchase Options

$190

Recorded Access Single User - 12 month

You'll have 12 month single user access to log-in for an archived recording of the entire 90 minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$499

Recorded Group Up to 10 Participants -12 month

You get up to 10 log-in for the live 90 minutes webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email

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