Quality Metrics Webinar
ISPE Quality Metrics Initiative
Following the passage of the US Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the FDA was authorized to collect manufacturing quality data from pharmaceutical companies and obtain certain records from a drug manufacturer in lieu of, or in advance of, an inspection. FDA also was directed to replace the previous two-year drug inspection frequency requirement with a risk-based inspection approach.
Each company tends to collect data in its own way for its own internal use, using a range of definitions and sampling plans. How firms measure and define “batch,” “lot,” and even “rejection” can differ among companies in different sectors, in the same sector, and even within the same company. Standardization is needed to ensure that the metrics reported to the FDA are defined and measured the same way by all.
ISPE has been bringing the pharmaceutical industry and regulators together to create an open dialogue on shaping the Quality Metrics program as it is launched industry wide. This webinar will help you learn more about this initiative and how it is impacting the pharmaceutical industry.
Learning Objectives
- Understand the genesis of the USFDA’s proposed Quality Metrics program.
- Discuss the challenges of defining, collecting, and reporting a standardized set of quality metrics.
- Assess the anticipated burden of collecting metrics as defined by the FDA in the 2015 Request for Quality Metrics draft Guidance.
- Gain an overview of statistically significant relationships between quality metrics and quality outcomes as revealed by the ISPE Quality Metrics Pilot Program.
R102.4 Quality Metrics Online Course
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 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 regarding potential regulatory metrics - what they might be, how they could be collected and used - to develop this very instructive webinar.