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

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

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

Carmody Quality Solutions, LLC (CQS), a consulting partner that provides quality management services to the pharmaceutical industry, announced a first-of-its-kind eBook that helps quality and compliance professionals develop a Voluntary Quality Assurance (VQA)® Culture The eBook “The Science... Read more

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

I love risk, and risk is something I live in every single day. I think it's really important to understand that when people talk about risk and FDA risk management, it's not about the elimination of all risk.... Read more

Guidance Inartfully Mixes New and Old Expectations – Creates Confusion for Drug and Biologics Manufacturers As the COVID-19 pandemic continues, FDA continues its efforts to steward public health decision-making in an increasingly challenging regulatory climate.  FDA’s most recent... Read more