Presented by: Gary Ritchie, Consultant, CAI
This webinar will cover the following topics:
• Stability test result deviations
• Quality Management System (QMS) elements for the following:
1) OOT/OOS
2) FDA notification Field Alert Report (FAR)
3) Corrective Action/Preventative Action (CAPA) remediation plan
• Statistically evaluate OOT
• Hypothesis Testing & Root Cause Analysis
• Conclude and document a root cause whenever possible
• Tools used to trend stability data
• Stability deviation report for OOT and OOS Decision Tree
• Evaluation of Stability Data Standard Operating Procedure