COURSE DESCRIPTION

OVERVIEW

Quality metrics are quantifiable measurements used to track and assess the value and performance of products, services and processes. Used in the pharmaceutical industry, quality 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.

In 2016, the FDA released a revised draft guidance, “Submission of Quality Metrics Data Guidance for Industry”, describing its Quality Metrics Reporting Program for drugs and biologics. New compliance and inspection policies could be developed as a result of submitted quality metrics. Establishing quality metrics now will help your company prepare for any future regulations as well as drive your Quality Culture toward continuous improvement.

This 90 minute interactive course will provide an overview of common quality metrics and why they are important. It will review tools used to measure and track quality metrics, as well as common errors associated with establishing metrics. We’ll show you how to drive Quality Culture through developing appropriate quality metrics that result in the behaviors you want.

LEARNING OBJECTIVES

At the end of the session, you’ll be able to:

• Recognize why metrics are important to both individuals and management
• Differentiate between Key Performance Indicators (KPIs) and metrics
• Identify common Quality metrics, associated mathematical equations and use of dashboards
• Recognize common errors associated with establishing metrics
• Utilize Quality metrics to improve both individual and company performance
• Review the contents of the FDA guidance on Quality Metrics.