Purpose

Plan, classify, assess, approve, implement and verify changes so that the validated state, the registered dossier and the quality agreements all survive, and the record proves it.

Learning outcomes

Decide what needs a change control, what is a like-for-like replacement, and what is a deviation in disguise
Classify changes as minor or major with a risk rationale that survives challenge, and map them to the EU variation categories under Regulation (EC) 1234/2008
Run a cross-functional impact assessment that covers validation, regulatory, quality agreements, supply, documentation and training
Sequence approval, implementation and verification so nothing goes live before the evidence exists
Define an effectiveness check that measures whether the change did what it was meant to, and close only when it passes
Apply Annex 11 and GAMP 5 to computerised system changes without a separate, weaker system

What the site gets back

A change record that an inspector can read cold: classification rationale, cross-functional impact assessment and evidence of verification before go-live
Templates (change request form, impact assessment, implementation and effectiveness plan) adopted by the team, so records are consistent across change owners
A certificate with a verifiable ID for the training matrix, checkable by an auditor
Fewer changes made before approval and fewer dossier mismatches, because the regulatory question is asked at classification, not at closure

Modules

1. Why changes fail: lessons from inspection findings
2. Change classification and regulatory impact
3. Impact assessment across QMS, validation and supply
4. Approval, implementation and verification
5. Effectiveness checks and closure
6. Change control for computerised systems

Regulatory mapping

EU GMP Ch. 1 (1.4(xi) change management); EU GMP Annex 15 (Section 11 change control); EU GMP Annex 11 (Section 10 change and configuration); ICH Q10 (3.2.3 change management system); ICH Q9 (R1) (Quality risk management); EU GMP Part II / ICH Q7 (Section 13 change control for APIs); ISO 13485 / MDR 2017/745 (7.3.9, 4.1.4; Annex IX substantial changes); Reg. (EC) 1234/2008 (EU variations: Type IA, IB and II).

Cost comparison. A two-day classroom course on the same topic typically costs €1,200 to €2,000 per person plus travel and two days away from the site. This course is priced for the waitlist launch for two and a half hours in the learner's own time. Team licences with a manager view and completion exports are available from the academy.