Free reading and free tools.
Start with The Warning Letter Brief — read the newest issue and search every past one in the archive. Further down are the tools you can run right now, and more show up here as they open.
The Warning Letter Brief
An operator's weekly read on new Warning Letters from the U.S. Food and Drug Administration (FDA): which few actually matter this week, what each one really says, and what to check on your own floor — with gemba-walk ideas (a simple "go and see" walk of the actual work).
Archived Weekly Briefs
Every past issue, newest first. Each week's new brief moves to the top and last week's drops into the archive.
The wildfire readiness drill
Take the site-leader chair at a fictional plant with a wildfire approaching. Make the calls under a live clock, then get a written coaching read-out — what went well, what to work on, and tips from your coach. It runs in your browser, and your results stay on your device; nothing is uploaded.
AI Governance Board Builder — concept demo
Walk through standing up an internal AI-governance board for a pharma site — charter, risk-tiering, validation posture, and operating rhythm — adjusted to the site profile you choose. Every approval seat stays with a named human; every result on the page was precomputed by the tested engine. An illustrative demonstration, not a validated product.
Prompt packs
Ready-made prompts your team can put to work — turning public enforcement records into a prevention brief for your own site. We'll post the free starter pack here when it's ready.
Common questions
What is the Warning Letter Brief?
An operator's weekly read on new Warning Letters from the U.S. Food and Drug Administration (FDA): which few actually matter that week, what each one really says, and what to check on your own floor — with gemba-walk ideas (a simple "go and see" walk of the actual work). Every issue is free to read.
How often does a new issue come out?
A new issue is written each week from the Warning Letters the FDA newly posted that week. The newest issue is linked at the top of this page.
What happens to my results from the wildfire readiness drill?
The drill runs entirely in your browser. Your results stay on your device; nothing is uploaded. Clearing your browser storage clears them.
Is any of this legal or regulatory advice?
No. Everything here is based on public FDA records and is for education and training only. PharmTech.AI is an independent service of Aligned Executive Solutions, Inc., not affiliated with, endorsed by, or sponsored by the FDA. A person reviews every output before it goes out.
PharmTech.AI is an independent service of Aligned Executive Solutions, Inc. It is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration. Everything here is based on public FDA records and is for education and training only — not legal, regulatory, or compliance advice, and not a gap assessment or audit. A person reviews every output before it goes out. Privacy Policy · Cookie Notice · Terms of Use