Implement structured CAPA methodology step-by-step to address EM excursions, verify effectiveness, and document actions in compliance with regulatory expectations.
Evaluate compounding-based CAPA case scenarios to distinguish between excursions, root causes, and system-level failures requiring corrective and preventive action.
Explain the role of the interdisciplinary team, including pharmacists, technicians, quality, leadership, and external stakeholders in developing, implementing, and sustaining effective CAPA processes.
