Sterile compounding environments are highly regulated and unforgiving of error. This session presents two real-world case study activities that demonstrate how effective root cause analysis and CAPA (Corrective and Preventive Action) planning can turn critical incidents into quality improvement opportunities. The first case explores a product investigation involving sterility and potency concerns in a compounded sterile preparation (CSP). The second focuses on an environmental monitoring excursion with out-of-limits (OOL) results for surface and viable air sampling. Attendees will gain practical tools for documentation, investigation, and team engagement, essential for maintaining compliance and patient safety.
Apply CAPA methodology step-by-step to address EM excursions, verify effectiveness, and document actions in compliance with regulatory expectations.
Analyze CAPA case studies from compounding practice 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.
