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Quality Management Seminar Wrap-Up: Risk and Harmonization , Part 1

  
  
  

Speakers from EtQ's Seminar on Life Sciences Quality management systems

This past week, we finished up a in-depth seminar in New Jersey.  The seminar, focused in the Life Sciences market, touched on the concepts of Global Harmonization and Standardization.  It also had a focus on Risk mitigation in Quality Management systems.  Overall, the seminar went well - great turnout, great speakers (great food), and overall a great response. 

Below is a recap of the first part of the conference:

Session 1:  Global Harmonization and the Enterprise Compliance System, presented by Morgan Palmer of EtQ, Inc.

In Morgan's presentation, he discussed how there is a constant pressure to diverge business systems, whether from product variety or cultural differences.  Specialization of these localized solutions and diverged product lines create a resistance to creating a single, Harmonized solution.  Harmonization is combining business systems into a single environment. By harmonizing your systems, you can alieviate some of the complexity in business systems.

Take Aways:

  • Systems are often disparate and businesses are looking to harmonize into a single holistic environment
  • Harmonization provides a common platform for systems, while enabling each business unit to keep their unique processes
  • Harmonization can reduce cost of support, system administration
  • Harmonization increases visibility across the enterprise
  • Harmonization increases knowledge sharing

Session 2:  Standard Processes for a Global Business, presented by David Kouchoukos, Johnson & Johnson

David followed up Morgan's presentation on the technical aspects of the Standardization and Harmonization approach with the "human element".  He focused on the critical elements for teams to be successful in standardization.  Essentially, the core elements of a good standardization project involve People, Processes, and Governance/Change Management.  Standardization should have:

  • Simplicity to reduce complexity
  • Integrated to other Quality processes and prodcut control systems
  • Standardizaed for all Divisions
  • Scalable to easily add other divisions and processes
  • Compliance to all applicable regulations

David went on to discuss the use of a standardization "Playbook" which is a structured process manual for standardization, and includes the best practices, defined roles, templates and project deliverables, all organized in a singular location.  This Playbook ensures the standardization principles are implemented effectively.

Take Aways:

  • Standardization is hard work, but brings significant benefit
  • You need to be willing to give a little in order to get a lot
  • Standardization projects need clear expectations, scope and deliverables
  • Needs Senior management support and Committment
  • Use a Playbook to ensure repeatable processes
  • Establish a governance, change management and change control process
  • Be flexible and adapt to business needs

Stay tuned for Part 2, where we cover Convergence and Risk Mitigation sessions from EtQ's Seminar on Risk Mitigation and Global Harmonization in Quality Management Systems.

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Comments

Hi I am with the IT compliance BU of one the largest global Pharmaceutical company. We are trying to harmonize global IT compliance processes. Am ready to share and interact on this topic. I would be purticularly interested on how to develop governance structure for the unified process.
Posted @ Wednesday, April 27, 2011 12:12 AM by Hari
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Posted @ Thursday, October 13, 2011 6:04 AM by iso 9000
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