Competency information
Details
Assist in the commissioning of a clean room/equipment following modification or installation.
Considerations
- How to support the audit process through prior self- inspection/internal audit.
- How to conduct a gap analysis and produce an action plan.
- How to store and retrieve key documentation.
- Clean room design and layout.
- User requirement specification for installation.
- Air handling plants.
- Work-flow optimisation, efficiency and safe working.
- Health Technical Memorandum 14/1.
- Requirements for commissioning of a clean room environment following modification or installation.
- How to complete a user requirement specification (URS).
- QMS and sign-off at design qualification, installation qualification, operational qualification, performance qualification.
- Fundamentals of project planning.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 | Outcome Assist in the training and monitoring of aseptic services personnel, ensuring competence and compliance with the relevant standards. |
| # 5 | Outcome Assist in the commissioning of a clean room environment/equipment following planned maintenance, modification or installation. |