The Golden Thread of Variability Reduction
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*Brian K Nunnally, Biogen Idec 

Keywords: Variability, Statistical Process Control, Deming

The pharmaceutical environment of the 21st century is focused on the understanding and control of variability. Regulatory agencies, the FDA in particular, are moving in the same direction as well. The recent Process Validation Guidance issued by the FDA is a perfect example of this trend. In this presentation, the linkage between the reduction of variability and the improvement in business and quality attributes are discussed. This sets the stage for improved production and increased compliance.