Blunt Talk from the FDA on Outsourcing Operations

Jack Garvey |

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

Why is Measuring Quality Culture Important for FDA Regulated Industry?

Jack Garvey |

Quality culture has been something that has been really hard to create tight, and kind of, geometric bounds around. But, in fact, it's something that's critically important for industry to understand how to essentially establish a measure of... Read more

FDA Inspections on Hold — But They’ll be Back. The Question is, Will You Be Ready? Highlights from FDLI’s Enforcement, Litigation, and Compliance Conference

Jack Garvey |

Now that the dust has settled from FDLI’s Enforcement, Litigation, and Compliance Conference and everyone is back to the new normal (Zoom calls, casual clothes and longer hours) we’ve had time to process our highlights from this great... Read more