Alan Greathouse

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The Process Validation Life Cycle

Posted by Alan Greathouse

As times change so do the expectations of the regulators. This holds true with validation as well. More global health authorities and regulators are communicating their expectations for risk and science based justification for process control and validation approaches. Let’s take a quick look at how the definition of Process Validation has evolved:

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A Look Back at FDA Approvals in 2016: The Downturn

Posted by Alan Greathouse

We all know 2016 was one for the ages and in the world of FDA Approvals the same can be said.

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