Quality Training

Investigation & CAPA Training

Objectives

Identify and distinguish between a correction, corrective action and preventive action.
Assess and evaluate risk.
Investigate events.
Conduct root cause analysis.
Identify a process to verify root cause.
Identify a process to implement corrective/preventive actions.

Content includes

Introduction - (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

Upcoming dates:

No training dates available at the moment.