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Heed the Warning (Letters)

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

Quality Quote of the Week

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

Cautionary Tales

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

Quality Quote of the Week

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

Recently Published Guidance from the FDA

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

Quality Quote of the Week

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

Quality Quote of the Week

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

Quality Quote of the Week

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

To Be Prepared (or Not to Be)

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

Quality Quote of the Week

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

Quality Quote of the Week

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

Knock, Knock

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

Quality Quote of the Week

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

The Only Thing You Have to Fear Is...

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...

Quality Quote of the Week

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...

Risk Averse?

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

Quality Quote of the Week

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...

Quality Quote of the Week

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

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