Perspectives on GMP training, pharmaceutical manufacturing, and building competency programs that survive regulatory scrutiny and actually work on the floor.
Why LMS implementation and administration is the difference between a training program that works and one that just exists — and the data goldmine most companies are sitting on without knowing it.
Something real is happening with AI in biopharma manufacturing training. Not the sci-fi fantasy vendors are pitching, but genuine, deployable technology. A practitioner's honest look at what works today, what's promising, and what's pure fantasy.
The cell and gene therapy CDMO market is projected to hit $52 billion by 2034. Everyone talks about capacity and capital. Almost nobody talks about the thing that will actually determine who wins and who chokes: training.
I've watched the same disaster movie play out at company after company for over a decade. The plot never changes. Now the FDA's own inspection data tells the story, with 85+ warning letters in 2025 and a 50% year-over-year increase in enforcement actions.
Most SOPs in pharma and biotech are written by the wrong people, for the wrong audience, using the wrong format. The result is procedures that satisfy auditors but confuse operators, and a deviation rate that never seems to improve.
Every biotech startup hits the same wall. Brilliant scientists, groundbreaking therapy, and investors who expect results yesterday. Training infrastructure is the last thing anyone wants to think about, until the first FDA inspection makes it the only thing.