The PQS model across the full product lifecycle, management responsibility, and how Q10 builds on Q8 and Q9.
This course covers the ICH Q10 pharmaceutical quality system model across the full product lifecycle, the management responsibility elements Q10 expects from senior leadership rather than QA alone, process performance and product quality monitoring expectations, and how CAPA and change management function as PQS enablers rather than standalone systems.
Q10 explicitly places quality system accountability with senior management, not just the quality unit. Sites that treat PQS as a QA-only responsibility miss what inspectors increasingly expect to see demonstrated at the leadership level.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
Start this course →