Blunt Talk from the FDA on Outsourcing Operations

I’ve read a lot of Warning Letters in my 30 years of working in FDA-regulated industry.  But one issued this week made me stop and think:  is the FDA getting blunter in its language? The Warning Letter was... Read more

How Do You Measure Quality Culture in FDA-Regulated Industry?

Quality culture can be extremely difficult to measure quantitatively...especially for companies regulated by the FDA. In this video, CEO Jack Garvey explains how organizations can begin to quantify their "quality culture" in an effort to benchmark and improve... Read more