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Description

Moderated by: Rick Burdick (Independent Consultant)
 
About the Webinar: Continued verification of pharmaceutical & biologic manufacturing processes is often performed using univariate statistical process control (SPC) charts with conventional mean +/- 3 SD limits. In cases where the number of attributes is large (e.g. 10 or greater) the false alarm rate (Type I error) for the overall system of charts is significant, resulting in overreaction to individual events and fulfillment of the dangers cited in the 2011 FDA process validation guidance. This has significant consequences for the utilization of resources in investigating such events as well as the potential for undermining the credibility and effectiveness of the monitoring program.

This webinar presents an alternative approach whereby more appropriate SPC limits may be applied to each attribute so as to minimize the system-level Type I error rate yet simultaneously detect unintended process variability.

Learning Objectives:

• Understand the significant potential for false alarms when using SPC charts for process and product monitoring.
• Learn how to minimize false alarms by adjusting the way statistical limits are calculated to account for anticipated process changes.