CDMO Governance & PIP
Most advanced therapies are made somewhere other than the sponsor's own walls. This pillar covers CDMO technical assessments and selection, person-in-plant oversight models, quality agreements, deviation and change control across a sponsor-CDMO boundary, and how to keep technical ownership of a process you do not operate day to day.
- Intermediate→Deviations and Change Control Across a CDMO Network: Who Really Owns What
How to run deviations, root cause investigations, CAPA effectiveness verification, and change control across a network of contract manufacturers, from what the quality agreement actually buys you to the metrics that reveal a partner's quality system drifting.
- Intermediate→Technical Assessment of a CDMO Before You Sign
How to run the technical assessment, capability, capacity, culture, equipment fit, analytical readiness, and data systems, that turns CDMO selection into a defensible technical agreement instead of a leap of faith.