Training and Qualification Lead
Establishes that people are competent to do GxP work, which is a different claim from establishing that they attended training. The regulation asks for the first and most systems record only the second.
8 FACETS · THREE ALTITUDES · FREE, NO ACCOUNT REQUIRED
What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
Kept on this device, and on your account when you are signed in. It orders your route; it never hides a page, and it is not a judgment about you.
You make sure everyone doing regulated work has actually been shown how, has demonstrated they can do it, and has a record proving both.
You run the training system against 21 CFR 211.25 and EU GMP Chapter 2 — role-based curricula, read-and-understand versus assessed competence, qualification for critical tasks such as aseptic technique and analytical methods, retraining triggers from deviations and procedure revisions, and the records that connect a person to a task on a date.
Training is where "human error" investigations either end honestly or end lazily. A training record that cannot distinguish exposure from competence turns every investigation into a retraining action that changes nothing.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
Between the procedures the organisation writes and the people expected to execute them.
- Procedure approval and role definition
- Investigations that identify a competence gap
- Any GxP task being performed by a qualified person
- Requalification following a procedure change
- Document control, so training is triggered by the correct procedure version
- Line managers who can assess practical competence
- Subject-matter experts to define what qualification means for a critical task
- Every function whose staff must be qualified before working
- Investigators testing whether a training gap contributed to an event
- Inspectors sampling personnel records against activities performed
- The training curriculum by role and its currency
- The distinction between awareness training and assessed qualification
- The record that a named person was qualified for a named task on a date
- The technical content of procedures
- The decision to assign a person to a task
- Performance management outcomes
- Quality assurance, where unqualified work has already been performed
- The department head, where a curriculum cannot be delivered within the operating schedule
- Role-based curricula and their revision history
- Qualification records for critical tasks, including practical assessment
- Retraining records traceable to the deviation or revision that triggered them
WHAT THIS ROLE CAN EVIDENCE · 0
No published competency maps to Training and Qualification Lead yet. 14 are published across the registry, and this role is not among the ones they name.
Read the standard and its stated coverage →STARTER KIT · 4
Templates and working tools for what this role produces or decides first. A starting shelf, not a complete one.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Quality Assurance pathway. No scenario exercises this role yet, so Practise comes later for it, then what any of it evidences. Skip any of them — the order does not change.
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- 21 CFR Part 211Current Good Manufacturing Practice for Finished PharmaceuticalsFDA · last revised 2024-06-18
- ICH Q9(R1)Quality Risk ManagementICH · last revised 2023-01-18
- ICH Q10Pharmaceutical Quality SystemICH · last revised 2008-06-01
- ISO 9001:2015Quality Management Systems — RequirementsISO · last revised 2015-09-15