Perspectives on GMP training, pharmaceutical manufacturing, and building competency programs that survive regulatory scrutiny and actually work on the floor. I began my career on the manufacturing floor, and I write with the people doing that work in mind.
The white paper, articles on AI governance and qualification, and the Life Sciences AI Academy, together in one place.
A biweekly Pharmaceutical Technology series on AI in biotech, viewed through the practical questions of quality systems, accountability, and governance.
Long-form analysis on the economics, qualification, and governance of AI-supported work in regulated pharmaceutical operations.
Articles and multimedia on AI governance, GMP decision authority, workforce qualification, and cell and gene therapy manufacturing. The latest AI Deep Dive article is featured above.
Where should an AI agent be allowed to observe, recommend, decide, or act in a GMP workflow, and where must an authorized person retain control?
Draft EU GMP Annex 22 limits generative AI in critical work. The article examines the controls manufacturers would still need if the proposed language changes.
AI pilots need more than model validation. People must be qualified for specific systems and workflows before organizations can rely on their use.
A proposed approach to linking controlled documents with applicability, role impact, curricula, qualification, and evidence, with human approval at key gates.
Experts from Sanofi, GxP Frame, and Open Biopharma discuss how AI is transforming discovery, manufacturing, workforce strategy, and strategic partnerships.
An FDA warning letter frames a closer look at human review, quality unit authority, and why accurate AI output alone does not establish a controlled process.
The cell and gene therapy manufacturing workforce is being asked to expand its deliverables while remaining undertrained.
Practical perspectives on training systems, procedural design, and manufacturing readiness.
Download the five-page review of identified FDA sources, guidance scope, and product-specific readiness questions. Revised September 2026.
The FDA softened CMC requirements for cell and gene therapy manufacturers. The flexibility is real, but most companies will misread it as permission to defer quality infrastructure, and pay for it at BLA.
Why LMS implementation and administration is the difference between a training program that works and one that just exists, plus 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.