Even when change is good, most of us would rather run the other way when we see it coming. This is simply human nature, especially when a system seems to be working satisfactorily. But the reality is ...

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice. FDA issued the guidance document Process Validation: General Principles ...

“High stakes tests” encompass any tests used to make significant decisions about a person’s care and are intimately tied to an individual’s medical treatment, social perception by others, and often ...

Human language and cognition represent one of the great paradoxes of the human species. They enable us to create science, develop technology, and connect in complex social ways. Yet, this very ...