FDA’s latest data should make any sponsor relying on a CDMO take a hard look at the site behind the application. In its FY2025 Report on the State of Pharmaceutical Quality, FDA analyzed nearly 10,000…
It is one of those risks that doesn’t announce itself. It just shows up quietly as AI works its way further into regulated life sciences. AI is not going away. It is going to end…
It was not thorough because it was long. It was thorough because it showed its work. It did not tell me the event was isolated. It showed me the four other places the same failure…
After enough years of getting calls from clients when an internal project has gone sideways or an audit has uncovered a problem, you start to hear the same sentence “I thought they had it.” It…
A quality meeting can feel productive and still leave the problem exactly where it was. The right people show up. The issue gets discussed clearly. Everyone agrees something needs to happen. But unless the meeting…
If Your Operation Touched An EUA, Start Looking For What It Left Behind U.S. Department of Health and Human Services (HHS) has announced the termination of the Emergency Use Authorization declarations for drugs and biological…
It Protects The Problem. That is where many quality systems begin to lose control. The deviation is documented, the immediate issue is contained, the form is completed, the CAPA is opened, and the record moves…
Most quality problems do not become serious overnight; they become serious when the organization gets used to working around them. A deviation takes too long to investigate, but the team has learned how to keep…
It is documentation that helps the next person understand what happened without having to track down everyone who was involved. That is a practical standard regulated teams can use every day. Before closing a CAPA,…
Incubators play a critical role in helping life sciences companies move from promising science to real company formation. They create access, focus, resources, relationships, and momentum at the stage when emerging companies need all of…
