Engineering Change Management for Pharmaceutical Capital Projects
Why Should You Attend:
Risk-based project delivery and verification processes as described by ASTM E-2500 have changed the roles of Engineering, Quality Assurance and Verification resources in the capital project environment and these changes have also affected how and when ECM is utilized and when the transition to formal Change Control processes occurs.
This 90 minute webinar presenttaion will help you understand the process and practical application of Engineering Change Management (ECM) in capital project delivery programs. We will discuss the key elements of ECM, when ECM is applicable and when it isn’t, and the regulations goverining Formal Change Control processes (which do not apply to ECM processes).
Areas Covered in the Seminar:
- Capital Project Delivery process and System Lifecycle Overview
- What constitutes a change?
- When is an ECM process not applicable?
- Other project change management processes
- Project Requests for Information (RFIs)
- Project Change Notices (PCNs)
- Approved Substitutions
- Scope of changes addressed by ECM vs. Formal Change Control
- Defining boundaries between ECM and Formal Change Control processes
- Managing change in a project environment for an existing facility
- Transition from ECM to Formal Change Control processes
- Regulations governing Formal Change Control processes
- Elements of an effective ECM process
Learning Objectives:
At the conclusion of this webinar, participants should be able to:
- Describe the Capital Project Delivery process and System Lifecycle Overview Understand the purpose and application of Engineering Change Management processes
- Describe what constitutes a change
- Identify the main elements of an effective ECM program
- Identify activities and events for which ECM is applicable and those for which it is not applicable
- Understand the events that trigger a transition from ECM to Formal Change Control
- Identify the regulations governing Formal Change Control processes (which do not apply to ECM processes)
- Identify the boundary between ECM and Formal Change Control processes in a project environment within an operating facility
