Lesson 2.1
Plan before you qualify
Connect a manufacturing need to evidence and an authorized decision.
Open lesson 2.1 →Module 02 · Self-study module
Validation Master Plan, URS and Risk Assessment
Turn a pharmaceutical project into a clear chain of requirements, risk controls and evidence.
10 narrated lessons40 explanatory visuals2 interactive explorersWorkbook + capstone
Start Lesson 2.1 →One project. Connected decisions.
Follow fictional mixing vessel V-201 from intended use through programme planning, requirements, risk assessment and handover. Designed for early-career pharmaceutical quality, validation, engineering and production colleagues.
Prerequisite: Module 1 — GMP Foundations.
Learn at your pace
Narration: 19.9 minutes across ten micro-lessons.
Allow roughly 4–5 hours for a beginner to read, draft answers and review; experienced learners may need less. Activity estimates total 210 minutes, plus about 20 minutes of narration and 30–60 minutes of reading/assessment. These are unmeasured planning estimates, not accredited contact time.
Use captions, the complete transcript or the illustrated reading path. The videos introduce the topics; required reading and worked examples supply additional assessed content.
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Course lessons
Lesson 2.2
Build a useful validation master plan
Distinguish programme governance from a protocol and a schedule.
Open lesson 2.2 →Lesson 2.3
System boundaries and responsibilities
Identify interfaces and avoid gaps between teams.
Open lesson 2.3 →Lesson 2.4
Write testable user requirements
Turn vague purchase language into verifiable requirements.
Open lesson 2.4 →Lesson 2.5
Trace requirements into verification
Follow a requirement from design to objective evidence.
Open lesson 2.5 →Lesson 2.6
Ask a precise risk question
Separate hazard, failure mode, harm and uncertainty.
Open lesson 2.6 →Lesson 2.7
Use FMEA without false precision
Apply a transparent scoring exercise and recognize its limits.
Open lesson 2.7 →Lesson 2.8
Turn risk controls into testable actions
Connect proposed controls to owners and evidence.
Open lesson 2.8 →Lesson 2.9
Read data before declaring success
Interpret a small illustrative dataset without overclaiming.
Open lesson 2.9 →Lesson 2.10
Capstone: make a defensible handover decision
Integrate the plan, requirements, risks and evidence.
Open lesson 2.10 →Keep a practical takeaway
Prepare an intended-use statement, programme outline, requirement list, traceability matrix, risk assessment and reasoned handover decision. Model answers support self-review.