This module is targeted for those outside of QA. The module will generally describe what is involved in the CAPA system pillar to provide context for those who are not directly involved. The module will also make connections to the role each person plays in the CAPA system and how it connects to the other pillars of Quality Systems and to the overall goal of Product Quality. Topics to discuss are deviations, investigations, CAPA, root cause analysis, and failure mode and effects analysis.


Please see section details for course meeting dates, times, and locations. Participants will be expected to spend time in between meetings completing activities designed to meet the module’s learning goals. The total time for each participant is 12 hours with three one-hour meetings.


This course requires TAK X401 Pharmaceutical Quality Systems: Overview to be completed before registering. 
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