Last week on LinkedIn, I shared a recently issued FDA Warning Letter that generated a lot of views and ‘likes.’ The topic of the...

There have been a number of draft and final guidance documents published by the US Food and Drug Administration (FDA) in the past several...

Earlier this week, I posted a quote about preparation and failure. While it might seem like a trite adage courtesy of Benjamin Franklin,...

I often emphasize that the FDA website has a wealth of publicly available information related to regulatory compliance, clinical research...

Two seemingly unrelated bits of information converged this week to put me in a reflective mood about how I have seen quality assurance...

I have been asked to provide ‘inspection readiness’ training many times. And while it’s tempting to do it with just one slide, more...

A colleague and I were recently sharing QA ‘war stories.’ She was relating to me her encounter with a, ‘But why?’ person in the GCP...