Week 14 — Dec 14: Final Exam
Cumulative final examination covering the whole course — the opening arc, risk, the analytical techniques, and the measurement on the process line.
**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 |
|---|---|
| 1–2 | The arc and risk management (assumed background) |
| 3 | NMR |
| 4 | UV-Vis and Beer’s law; dissolution; atomic spectroscopy and Q3D |
| 5 | Molecular spectroscopy and the solid-state toolbox |
| 6 | Separations — theory, method development, stability-indicating methods, CE, wet-chemistry workhorses |
| 8 | Mass spectrometry; ion suppression; MAM |
| 9 | AI & the regulatory landscape; model vs method validation; the M7 (Q)SAR case |
| 10 | Machine learning & chemometrics — preprocessing, PCA, PLS, MCR, DoE, overfitting |
| 11 | PAT, RTRT, continuous manufacturing, the model lifecycle |
| 12 | Large molecules & biologics — the CQA panel, potency, particles, comparability |
| 13 | Advanced therapies — gene, cell, mRNA-LNP, oligonucleotides |
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” questions throughout: not only what a technique measures, but what decision it supports, how the result is defended to a regulator, and how it fails.