Definition and Sources of Variation Identified in Validation Processes

At IVT's Validation Week EU, Dawn Tavalsky led the attendess through an investigation of types of variation found in validation processes. As Tavalsky explained, variation can be classified into either common, or natural, cause and special cause. She further defined and explained process control, capability, process analytical technology, and the US Food and Drug Administration's definition of variation. Moving onto the sources of variation, she illustrated commonly overlooked sources of variation, citing examples of human error and machine errors. Finally, Tavalsky explained how the components of variation will differ from total process variation to inherent process variation.

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