Operationalizing a Quality Metrics Program: Critical Success Factors

Metrics programs should be a core part of a company's Pharmaceutical Quality System. This online course is designed for every person who is involved in a metrics program, including operators and quality control personnel who contribute to generating the raw data, through to those involved in collecting, submitting and, most importantly, analyzing the data, drawing conclusions, and taking relevant and necessary actions to implement continual improvement projects.

Following the passage of the USFDA Safety and Innovation Act (FDASIA) of 2012, the FDA is considering the utilization of quality metrics as an input to its inspection models to determine inspection schedules for manufacturers, as well as to assist in the prediction of possible drug shortages. Metric data, as well as other information available to the agency, may assist with the amendment of post-market change reporting requirements and re-structure the frequency and format of inspection. To that end, after receiving input from industry on which metrics manufacturers use and find effective to measure quality performance the FDA issued two draft guidances, one in 2015 and a revision in 2016.

This online course teaches the role of quality metrics within a company's Key Performance Indicator (KPI) program using the extensive experience ISPE gained from two extensive pilot programs undertaken in collaboration with McKinsey and Company and with participation from 28 companies and 83 sites. The participating companies and sites represented a wide range of technologies and included contract manufacturing organizations (CMOs) and laboratories, and drug substance manufacturing sites. ISPE used this vast breadth of experience and engagement with companies in regard to potential regulatory metrics - what they might be, how they could be collected and used - to develop this very instructive webinar.

Course Modules/Learning Objectives

  • Demonstrate how to clearly identify and develop a standardized collection process for metric data for various sites including a section on definitions, how to clearly define data elements to minimize gaming and understand how regulatory metrics fit in a wider quality metrics program.
  • Discuss the need for standardization in order to acquire real and comparable data and demonstrate how to clearly identify and develop a standardized collection process for metric data.
  • Provide knowledge to apply information gained from harmonized Quality Metrics.
  • Understand the relationships and where there may be more leading/culture indicators that can inform our understanding of change within a site and consequentially inspectional risk. Review how Recurring Deviations were found from Wave 1 and 2 Pilots to be valuable.

Attendance suggested for:

  • Quality assurance/quality control personnel with the responsibilities for the quality system and collecting, analyzing the quality metrics.
  • Management responsible for the quality system and its improvement through the creation, reporting, or handling of quality data.
  • Production staff with the responsibility for the quality process and production.


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