Week 7 — Oct 26: Mid-Term Exam
Mid-term examination covering Weeks 1–6: the opening arc, analytical methods development and the modality landscape, quality risk management and FMEA, atomic spectroscopy, and UV-Vis / molecular spectroscopy — with NMR as background from the MAI-led sessions.
**Clear your calendar for this session.** The mid-term is held in the normal class slot.
(Not a lecture.) The mid-term marks the end of the first half of the course.
Coverage
| Weeks | Material |
|---|---|
| 1 | The opening arc — analysis as science / STEAM, the molecule-to-market funnel, the ICH framework and compendial methods, clinical development as uncertainty reduction, quality control, automation, knowledge management, cost |
| 2 | Analytical methods development and regulatory context; the modality landscape (small molecule, large molecule, advanced therapy) and why small molecule dominates entry-level hiring; ICH Q9, the risk toolbox, FMEA and RPN, risk assessment → control strategy |
| 3–4 | NMR spectroscopy (MAI) — background only, unless included at the instructor’s discretion |
| 5 | Atomic spectroscopy and ICH Q3D — elemental impurities, the risk-homework checkpoint |
| 6 | UV-Vis and Beer’s law; IR/Raman/NIR molecular spectroscopy; reading a Certificate of Analysis |
Format
(Instructor: fill in — number of questions, open/closed book, calculator policy, weighting toward interpretation vs recall, whether the Weeks 5–6 risk-assessment assignments are due at the exam, and whether MAI’s NMR material from Weeks 3–4 is in scope.)
What is being tested
Consistent with how the course is taught: not just what each technique measures, but what decision the measurement supports and how you would defend the result — the recurring “For discussion” and “On the job” material is the best guide to the style of reasoning expected.