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Engineering Change Management for Pharmaceutical Capital Projects
Wednesday, March 6, 2013 from 10:00 AM to 11:30 AM (PST)
Palo Alto, CA
This pharmaceutical project management training will help you understand the process and practical application of Engineering Change Management (ECM) in capital project delivery programs.
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
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.