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This presentation will provide a practical and detailed road map of how to develop and implement an ECM program in the pharmaceutical manufacturing industry

Abstract

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 regards 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 Change Management Document. The presentation also includes a risk-based strategy to develop pre-assessment requirements and categorization for the proposed Engineering Changes.

Event Location

Online, Zoom, a link will be send prior the event.

Event Agenda

  • 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

Attendee Registration

Registration Category

Emerging Leaders
$15

ISPE Member
$20

Non-Member
$30

Speakers

Out of stock

Engineering Change Management (ECM) - August 10th, 2021

ATTENDEE REGISTRATION – Engineering Change Management

$30.00