US FDA

Contract Manufacturing Oversight

What a compliant quality agreement must define, and where oversight responsibility cannot be delegated to a CMO.

What this course covers

This course covers FDA's expectations for owner oversight of contract manufacturing organizations, what a compliant quality agreement must actually define, and the audit and qualification requirements that apply before and during a CMO relationship. It is specific about where responsibility is shared between owner and CMO, and where it legally cannot be delegated away.

Who this course is for

Quality and supply chain staff overseeing contract manufacturers
Anyone drafting, reviewing or auditing against a quality agreement

What you'll learn

FDA's expectations for owner oversight of contract manufacturing organizations
What a compliant quality agreement must explicitly define
Audit and qualification requirements that apply before and during a CMO relationship
How responsibility is shared between owner and CMO, and where it cannot be delegated
The most common CMO oversight gaps identified in FDA warning letters

Why it matters

FDA has been explicit that outsourcing manufacturing does not outsource accountability. A significant share of warning letters involving contract manufacturers cite the product owner directly, not just the CMO, for inadequate oversight. A well-built quality agreement is the foundation that oversight depends on.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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