Change control and lifecycle management

Decision to master

Assess a change's impact, define its approval strategy and control its lifecycle.

Learning objectives

• Explain the quality intent associated with "Change management".
• Identify the risks, responsibilities and evidence expected in a professional situation.
• Formulate a proportionate, traceable and defensible decision.

Indicative programme

1. Change request: impact assessment and classification
2. Implementation plan: validation, training, documentation
3. Approval, deployment and post-implementation review
4. Lifecycle management: retrospective and improvement

Prerequisites

• GMP fundamentals and quality system
• Experience in quality documentation management