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Welcome, ISPE Canada Affiliate
Engineering Change Management (ECM)
10 August 2021 | 17:00-18:00
This presentation will provide a practical and detailed road map of how to develop and implement an ECM program in the pharmaceutical manufacturing industry
In the pursuit of adopting a risk-based approach to commissioning and qualification, an Engineering Change Management (ECM) program can be developed to complement a Quality Change Control program. An ECM program ensures that all non-critical changes within the GMP space and all changes outside the GMP space are documented, tracked, and managed.
An established ECM program is a critical characteristic indicator of an organization’s maturity level with regard to its ability to determine the degree and pace of its transition into a risk-based approach for commissioning and qualification of equipment, facilities, and related systems.
This presentation will provide a practical and detailed road map of how to develop and implement an ECM program in the pharmaceutical manufacturing industry.
In addition, this presentation will explain the differences between a change control record and a change management document. The presentation also includes a risk-based strategy to develop pre-assessment requirements and categorization for the proposed engineering changes.
Tuesday, August 10, 2021
Introduction
The Problem
The Solution
ECM vs. QCC
ECM within RBA (Risk-Based Approach)
In-House Implementation Must-Haves!
The Ultimate Goal
ECM Potential Scenarios
ECM Approval Matrix
ECM Forms… Standard fields
ECM Forms… Specific fields
Conclusion
infographic
Q&A
Event Location
Online, via Zoom, a link will be sent prior to the event.
Attendee Registration
| Registration Category | Fee |
|---|---|
| Emerging Leaders | $15.00 |
| ISPE Member | $20.00 |
| Non-Member | $30.00 |
Register now to attend this event
Event Speakers
NOTE: For other sponsor opportunities, please contact Dina Iezzi 647-234-3395