Training activity information

Details

Produce necessary documentation for a new, aseptically prepared product, following an appropriate change control process

Type

Developmental training activity (DTA)

Evidence requirements

Evidence the activity has been undertaken by the trainee​.

Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.

An action plan to implement learning and/or to address skills or knowledge gaps identified.

Considerations

  • Regulatory requirements and National guidance
  • Local SOPs
  • Change control
  • Risk assessment
  • Stability/shelf life
  • Packaging
  • Route of administration
  • Product types
  • Patient acceptability
  • Product specifications
  • Validations
  • Design and preparation of worksheet(s)
  • Design and preparation of SOPs
  • Design and preparation of labels
  • Staff training

Relevant learning outcomes

# Outcome
# 5 Outcome

Develop and implement standard operating procedures (SOPs) and related documentation for a range of processes.

# 6 Outcome

Apply risk management techniques in the context of aseptic medicines.