Manufacturing and Production

Deviation, CAPA and Quality Risk Management in Pharmaceuticals

Most corrective actions in pharmaceutical manufacturing are retraining the operator, which is what an investigation concludes when it stops at the person nearest the event. This course goes past that. Delegates work through deviation classification and the criteria that separate a minor event from one requiring full investigation. Immediate actions and product impact assessment follow, including the decision on batches already made and released. Root cause analysis is covered with techniques that resist the obvious answer, and the discipline of testing a hypothesis against the evidence. Corrective and preventive action design is addressed, including effectiveness checks and the difference between correcting an event and preventing its recurrence. Quality risk management is covered as a working method: risk identification, analysis, evaluation and control, applied to real decisions rather than to a filed assessment. Trending across deviations follows. Complaint handling and recall decisions are addressed. The course closes on inspection readiness and on the state of a quality system that keeps repeating deviations.