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 ...
Improving efficiency is complex and requires a multimodal approach. Health information systems, patient feedback, and multidisciplinary teams are components that can improve clinical processes.
The era that spawned Enron, Tyco and Adelphia has turned, and on its heels is a new trend to get back to the basics of ethical business practices. In my role as a process analyst, I’ve found that the ...
An agile approach gives you the chance to try new methods, while constantly reviewing progress. Unfortunately, that’s completely foreign to the way in which most businesses run. All too often, ...
“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 ...
Good writing may be magical, but it’s not magic. It is the by-product of a rational series of decisions and actions. Fortunately for those of us struggling to write well, that process can be observed, ...
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 ...
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality ...
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