US FDA

FDA Process Validation - General Principles and Practices

FDA's three-stage lifecycle approach to process validation: process design, process qualification and continued process verification.

What this course covers

This course works through FDA's 2011 Process Validation guidance and its three-stage lifecycle model: process design, process qualification, and continued process verification. It covers the statistical approaches used to demonstrate process capability, what a defensible validation protocol and final report need to contain, and how ongoing monitoring data feeds back into continued verification rather than being collected and filed away.

Who this course is for

Validation engineers building or executing process validation protocols
Manufacturing and quality staff involved in PV studies
Anyone transitioning from the older three-batch validation mindset to the lifecycle approach

What you'll learn

FDA's three-stage lifecycle model for process validation, and why it replaced the old three-batch approach
The distinct goals of process design, process qualification and continued process verification
Statistical approaches used to demonstrate genuine process capability, not just passing results
What a defensible process validation protocol and final report actually need to contain
How ongoing monitoring data should feed back into continued process verification

Why it matters

Sites that still treat process validation as a one-time three-batch exercise are increasingly exposed at inspection, since FDA's expectation has been the full lifecycle model for well over a decade. Continued process verification is the stage most often neglected, and it is the one inspectors ask about first.

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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