I found a recent FDA Warning Letter issued to a Clinical Investigator for a pediatric flu vaccine study quite interesting. A few points I...

Good leaders are good listeners. To be most effective, they follow this pattern: Listen, learn, then lead. - John Maxwell #quotes

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

"Celebrate what you want to see more of." - Tom Peters #quotes

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

"Today expect something good to happen to you no matter what occurred yesterday." - Sarah Ban Breathnach #quotes

“If you don't know where you are going, you'll end up someplace else.” - Yogi Berra #quotes

"Quality means doing it right when no one is looking." - Henry Ford #quotes

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

“By failing to prepare, you are preparing to fail.” ― Benjamin Franklin #quotes

After the past few weeks of tragic news and any personal challenges we all may have faced, let’s end this week with a few uplifting...

We are what we repeatedly do. Excellence, then, is not an act, but a habit. - Aristotle #quotes

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

The Principle of Priority states (a) You must know the difference between what is urgent and what is important, and (b) You must do...

In last week’s blog, Risk Averse? [31-Jan-2018], driving to work was used as an example to alleviate anxiety about risk assessment and...

It does not do to leave a live dragon out of your calculations, if you live near him. - J.R.R. Tolkien This week's quote may be a...

Sometimes, when I start talking about ‘risk assessment’ and ‘risk management’ in GCP settings, looks of confusion or fear stare back at...

By asking questions instead of letting assumptions go unchecked, you can bring solutions to the surface. - Adam Waytz #quotes

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

Don’t find fault, find a remedy. - Henry Ford This very short quote is a good reminder that effective root cause analysis needs to...