Stability Deviations & Out of Trend / Out of Specification ( OOS/OOT )

Presented by: Gary Ritchie, Consultant, CAI • Stability test result deviations• Quality Management System (QMS) elements for1) OOT/OOS2) 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 […]

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Presented by: Gary Ritchie, Consultant, CAI • Stability test result deviations• Quality Management System (QMS) elements for1) OOT/OOS2) 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 […]
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  • Email: info@kenx.org
  • Phone: 858 649 3251
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