Competency information


Gain approval to implement (or not) your changes following assisting and writing up of an audit. 


  • Purpose of change management to manage change to prevent unintended consequences.
  • Effective change control activities:
    • quality planning and control of revisions to specifications
    • process parameters
    • procedures.
  • Responsibilities of the quality control unit.
  • Regulatory approval processes.
  • Local governance.
  • Standard operating procedures.

Relevant learning outcomes

# Outcome
# 5 Outcome Use a change control system to document a change to a product, facility, or controlled documentation.