Manage deviations from first detection to effective CAPA. Learn what a deviation is, types and categories, risk-based classification, the end-to-end deviation process, how to write a clear deviation report, investigation and root cause analysis, impact assessment and batch disposition, CAPA, trending and metrics, and the deviation findings inspectors raise most often.
Handle out-of-specification, out-of-expectation and out-of-trend results the way regulators expect. Learn what OOX means, how to run a Phase 1 laboratory investigation, when and how to move to a full-scale Phase 2 investigation, the rules for retesting and resampling, closing investigations with CAPA, OOE and OOT trending, and how OOX applies in calibration, method transfer, validation and outsourced testing.
Run investigations that inspectors trust: how deviations flow into the CAPA system, detection, impact assessment and triage, problem definition, root cause tools, human error and laboratory OOS investigations, CAPA plans with effectiveness checks, and clear investigation reports.
Build a CAPA system that actually prevents recurrence: maturity assessment, problem statements, root cause analysis, action planning, effectiveness checks, KPIs, governance and continual improvement.
نظام الإجراءات التصحيحية والوقائية — دورة فيديو تفاعلية بتعليق صوتي إنجليزي ونصوص ثنائية اللغة (إنجليزي / عربي).
Course modules
- What CAPA Really Is
- Measuring CAPA Maturity
- Documentation and Problem Identification
- Root Cause Analysis
- Corrective and Preventive Actions
- Effectiveness Checks and Metrics
- Governance and Leadership
- Improving Your CAPA System
Instructor: Rafat Alghubari — GxPeria Founder & MD.
For education only — always follow the official guidance and your site procedures.