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.
Attendance suggested for: