**Clear your calendar for this session.** The final is held in the scheduled examination slot.
(Not a lecture.) The final is cumulative. It is weighted toward the second half of the course but assumes the opening arc and risk framework as working background.
Coverage
| Weeks | Material |
|---|---|
| 1 | The opening arc — analysis as science, the molecule-to-market funnel, ICH framework, clinical development, quality control, automation, knowledge management, cost |
| 2 | Analytical methods development and regulatory context; the modality landscape (small molecule, large molecule, advanced therapy); ICH Q9, the risk toolbox, FMEA and RPN |
| 3–4 | NMR spectroscopy (MAI) — background only |
| 5 | Atomic spectroscopy and ICH Q3D — the first risk-homework checkpoint |
| 6 | UV-Vis and Beer’s law; molecular spectroscopy (IR/Raman/NIR); reading a Certificate of Analysis — the second risk-homework checkpoint |
| 8 | Separation Methods — chromatographic theory, method development, stability-indicating methods, system suitability, the wet-chemistry workhorses, and separations applied to biologics/advanced therapies |
| 9 | Specialized & Solid-State Characterization — DSC/TGA, XRPD and X-ray crystallography, flow cytometry, and dissolution |
| 10 | Mass spectrometry fundamentals and ion suppression, applied to small molecules and biologics/advanced therapies — the third risk-homework checkpoint |
| 11 | PAT and automation — the measurement hierarchy, RTRT, continuous manufacturing (ICH Q13), the model lifecycle, complaints and pharmacovigilance |
| 12 | Chemometrics and miscellaneous methods — AI/ML governance and the regulatory landscape; PCA, PLS, MCR, DoE, overfitting |
Format
(Instructor: fill in — duration, open/closed book, calculator and reference-sheet policy, balance of short-answer vs extended reasoning, and the weighting of interpretation and defence-of-result questions relative to recall.)
What is being tested
The same standard as the “For discussion” and “On the job” material throughout: not only what a technique measures, but what decision it supports, how the result is defended to a regulator, and how it fails — and whether you could actually do the job it belongs to.