Engineering Change Management for Pharmaceutical Capital Projects 2013

Key Topics

• Describe what constitutes a change
• Describe the Capital Project Delivery process and System Lifecycle Overview Understand the purpose and application of Engineering Change Management processes
• Identify activities and events for which ECM is applicable and those for which it is not applicable
• Identify the main elements of an effective ECM program
• Identify the regulations governing Formal Change Control processes (which do not apply to ECM processes)
• Understand the events that trigger a transition from ECM to Formal Change Control
• Identify the boundary between ECM and Formal Change Control processes in a project environment within an operating facility

Who should Attend

• Project Management
• Engineering
• Commissioning and Qualification
• Construction
• Quality Assurance