| Course | Learning | Knowledge paper | Written capstone | Viva | Total hours |
|---|---|---|---|---|---|
| 1 | 29.5 | 0.5 | 0.0 | 0.0 | 30.0 |
| 2 | 35.25 | 0.75 | 0.0 | 0.0 | 36.0 |
| 3 | 29.5 | 0.5 | 0.0 | 0.0 | 30.0 |
| 4 | 22.75 | 0.5 | 6.0 | 0.75 | 30.0 |
| 5 | 23.5 | 0.5 | 0.0 | 0.0 | 24.0 |
140.5 learning hours + 9.5 formal-assessment hours = 150 hours. Assessment reserves replace part of the former guided practice allocation. They are delivered in the supervised windows below. Optional extensions, breaks and reassessments are additional.
Read the complete programme handbook and assessment policy
45-topic delivery map
| Topic | Guided learning (min) | Reserved assessment (min) | Total allocation (min) |
|---|---|---|---|
| C1 · M1 — The system as a system | 225 | 0 | 225 |
| C1 · M2 — Senior management and management review | 225 | 0 | 225 |
| C1 · M3 — Risk as the working method | 225 | 0 | 225 |
| C1 · M4 — Change management | 225 | 0 | 225 |
| C1 · M5 — Deviations, investigations and CAPA | 225 | 0 | 225 |
| C1 · M6 — Monitoring, the product quality review and knowledge | 225 | 0 | 225 |
| C1 · M7 — Outsourced activities, suppliers and self-inspection | 225 | 0 | 225 |
| C1 · M8 — Data governance: the records the system relies on | 195 | 30 | 225 |
| C2 · M1 — The mandate | 120 | 0 | 120 |
| C2 · M2 — The sixteen elements | 120 | 0 | 120 |
| C2 · M3 — Rooms, air and pressure | 150 | 0 | 150 |
| C2 · M4 — People | 120 | 0 | 120 |
| C2 · M5 — Utilities, materials and closure | 150 | 0 | 150 |
| C2 · M6 — Process, simulation and sterilisation | 150 | 0 | 150 |
| C2 · M7 — Monitoring, trending and investigation | 150 | 0 | 150 |
| C2 · M8 — Governance and the living document | 120 | 0 | 120 |
| C2 · M9 — The document itself: a worked example | 150 | 0 | 150 |
| C2 · M10 — The findings, in the inspectors' own words | 120 | 0 | 120 |
| C2 · M11 — Pharmaceutical microbiology: the organisms, the counts and the limits | 150 | 0 | 150 |
| C2 · M12 — Endotoxins and pyrogens | 180 | 0 | 180 |
| C2 · M13 — The sterility test and its limits | 150 | 0 | 150 |
| C2 · M14 — Identification, trending and the environmental monitoring programme | 150 | 0 | 150 |
| C2 · M15 — Aseptic process simulation, designed | 135 | 45 | 180 |
| C3 · M1 — From the user requirement to performance qualification, as one chain | 225 | 0 | 225 |
| C3 · M2 — Process validation across the lifecycle: traditional, continuous, hybrid, and ongoing verification | 225 | 0 | 225 |
| C3 · M3 — Cleaning validation with health-based exposure limits | 225 | 0 | 225 |
| C3 · M4 — Computerised systems: Annex 11 from validation to retirement | 225 | 0 | 225 |
| C3 · M5 — Requalification, maintenance and the state of control | 225 | 0 | 225 |
| C3 · M6 — Verification of transportation | 225 | 0 | 225 |
| C3 · M7 — Validation of packaging and the closed container | 225 | 0 | 225 |
| C3 · M8 — Change control across the lifecycle | 195 | 30 | 225 |
| C4 · M1 — The person the law names | 225 | 0 | 225 |
| C4 · M2 — Certification and release are two acts | 165 | 60 | 225 |
| C4 · M3 — The twenty-one points | 165 | 60 | 225 |
| C4 · M4 — Many sites, many signatures | 165 | 60 | 225 |
| C4 · M5 — Across the border | 165 | 60 | 225 |
| C4 · M6 — The deviation on the desk | 165 | 60 | 225 |
| C4 · M7 — After the signature | 165 | 60 | 225 |
| C4 · M8 — Independence, delegation and the register | 150 | 75 | 225 |
| C5 · M1 — The laboratory the guide describes | 240 | 0 | 240 |
| C5 · M2 — Validation across the lifecycle: ICH Q2(R2) and Q14 | 240 | 0 | 240 |
| C5 · M3 — Specifications and impurities | 240 | 0 | 240 |
| C5 · M4 — Stability in the laboratory | 240 | 0 | 240 |
| C5 · M5 — Out of specification | 240 | 0 | 240 |
| C5 · M6 — Method transfer | 210 | 30 | 240 |
Supervised assessment windows
| Activity | Minutes | Scheduling |
|---|---|---|
| Course 1 knowledge paper | 30 | After the course teaching; one controlled sitting |
| Course 2 knowledge paper | 45 | After the course teaching; one controlled sitting |
| Course 3 knowledge paper | 30 | After the course teaching; one controlled sitting |
| Course 4 knowledge paper | 30 | After the course teaching; one controlled sitting |
| Course 5 knowledge paper | 30 | After the course teaching; one controlled sitting |
| Integrated written capstone | 360 | One six-hour sitting; budget reserved across C4 M2–M7. Issue Packet A at three elapsed hours. |
| Individual viva | 45 | After the written assessment; budget reserved in C4 M8. |
Using the teaching resources
The full teaching explanations, cases and worked examples remain available. Follow the revised phase timers. The capstone replaces selected classroom practice; additional prompts are alternatives when time permits. Keep the 45 individual portfolio outputs and use the competency map to check coverage. Record actual minutes and reviewed evidence in the cohort master.
At least 90% of scheduled facilitated learning per course, approved make-up where needed, all mandatory outputs, all five knowledge papers and the capstone standard are required. A browser tick is not an attendance or assessment decision.
One complete module per course remains free; the other 40 modules and their instructor resources retain the existing QP access controls.