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…
FDA inspection and enforcement activity is moving faster, becoming more data-informed, and placing greater pressure on companies to prove control before, during, and after inspection. That matters for every biologics, cell and gene therapy, and…
The wrong vendor does not feel expensive at first. They feel expensive when your team has to manage the work they were hired to own. When scope is unclear, schedules slip, communication is weak, deliverables…
AI is moving into life sciences quality and manufacturing work, and FDA is showing how existing GMP expectations apply when AI is used to support regulated activities. FDA has already used enforcement to make clear…
FDA is making one point increasingly clear. You can outsource manufacturing, but you cannot outsource oversight. That principle extends across outsourced manufacturing, testing, and critical supplier oversight. Whether the work is performed by a CDMO,…