Investigation & CAPA Training
ObjectivesIdentify and distinguish between a correction, corrective action and preventive action.
Assess and evaluate risk.
Conduct root cause analysis.
Identify a process to verify root cause.
Identify a process to implement corrective/preventive actions.
Content includesIntroduction - (Introduction to the Investigation & CAPA concepts and principles. Discuss what drives the investigation system, the regulatory implications, and key definitions.
Evaluate - Identify and prioritize events, break them down into specifics, develop accurate and effective problem statements. Tools and resources to aid in investigations: Asking effective questions, conducting interviews, then determine best path forward based on risk.
Investigate - Investigate systematic issues for underlying causes. Use tools to identify trends and root cause(s) such as: Deductive Reasoning, SPC tools, 5-Whys, Fish Bone Analysis, and Is/Is not.
Implement - Identify and select solutions including corrective and preventive actions. Create and execute plans for implementation activities. Measure effectiveness through verification and validation.
Who should attend
No training dates available at the moment.