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6 articles tagged field notes.
A composite of practitioner conversations on FDA and EU inspections that put process analytical technology and chemometric models in scope. Inspectors read the lifecycle records, not the qualification protocols.
A composite of conversations with validation engineers working on pharmaceutical and biopharmaceutical PAT installations. The hardest parts of the job sit at the seams between project, quality, and operations.
A composite from mid-market plants in Central and Eastern Europe on what it means to buy process analytics from a vendor that is not Thermo, Agilent, or Mettler. The list is longer than the catalogue.
A composite of conversations with engineers running multi-site PAT programs. The technical work is straightforward; the parts that go wrong are organizational, contractual, and cultural.
A composite of observations from PAT projects where the model team and the line team had everything they needed except a shared vocabulary. What both sides actually mean by the words they use.
A composite of observations from practitioners who have worked PAT projects on both pharmaceutical and bulk-chemicals sites. The instrument is often the same; almost everything around it is different.