IPQ Inside the global regulatory dialogue

Clarifying Questions Upfront is Key in Process Validation, US and EU PV Principles in Alignment, CDER’s McNally Stresses 

Oct 29th, 2015

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FDA’s basic PV philosophy, which lines up with that in Europe, she emphasized, is “declare and be clear on what it is you are trying to prove. Then design the study to get the data...

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