Senior Principal Scientist Merck Sharpe and Dohme LLC West Point, Pennsylvania
Measurement System Analysis (MSA) and Statistical Process Control (SPC) are used to ensure robust Analytical Method performance by monitoring key analytical metrics over time. During method development, key metrics of the analytical method are determined, statistical analysis is performed on those metrics to establish a baseline of performance to establish control limits, and those metrics are monitored over time during routine method application to alert potential issues prior to an actual method failure.
Learning Objectives:
understand the basic fundamentals underlying the statistical assessment of analytical method performance
use Statistical Process Control (SPC) to monitor analytical method performance over time
combine Measurement System Analysis (MSA) with SPC to monitor method performance for contrinuous process verification and improvement.
