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5 clinical overview - PowerPoint PPT Presentation

Validation is Always Part of the Picture

Validation is Always Part of the Picture. Commercial Manufacturing. Pre-IND. Phase I. Phase II. Phase III. Final process validation. Specification Development. Re-validation. Ongoing Validation (DOE, IQ, OQ, PQ, PV)*. * DOE = Design of Experiment IQ = Installation Qualification

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5 clinical overview - PowerPoint PPT Presentation

Validation is Always Part of the Picture