Course Learning Outcomes
- Explain and apply core cGMP principles in GMP aseptic settings
- Build EM approaches that support contamination prevention and control
- Consolidate microbiology knowledge: microorganism types, growth conditions, and risk to product quality/safety
- Reinforce cleanroom compliance: PPE, gowning, hygiene, and controlled-environment behaviours
- Become familiar with sampling techniques and regulatory compliance requirements used in testing for microbiological and particulate monitoring
- Develop confidence in correct documentation for compliance and traceability (aligned to data integrity / ALCOA++)
- Learn real-time practical responses and appropriate interventions to deviations or non-compliances: pathways to escalation and investigational support of resulting CAPAs
- Understand and apply latest regulatory updates in your facility e.g. EU GMP Annex 1 expectations for EM and microbiology in routine and atypical events
Who it’s for:
QC Micro/EM, GMP Processing Scientists, QA/QC Teams, Facilities/Cleanroom support; Validation/MSAT/PAT and Tech transfer roles needing cross-functional alignment.
Expect learning that builds confidence to:
- apply GMP basics in controlled environments
- practise EM and sampling/testing approaches
- understand microbiology fundamentals and contamination risk
- document correctly for compliance and traceability (ALCOA++)
- respond appropriately to deviations and support CAPA
- apply relevant regulation expectations including EU GMP Annex 1
