How to Manage Change in a cGMP Environment - Webinar

  • ID: 3734845
  • Webinar
  • 60 Minutes
  • Pathwise
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A robust Change Control process is a vital part of a compliant Quality System. The purpose is to deal with change in a controlled manner. Change is a constant and expected process hence not managing it will leave you in the dust. As Heraclitus said "The only thing that is constant is Change."

With Change come consequences; some intended, some not, some desirable, some not. Based on regulatory expectations, all changes must be assessed for their impact on safety, quality, identity, purity, potency, and strength (SQIPPS) prior to commercial distribution and clinical trials intended for human use. These changes could be related to product, process or systems. Based on business needs, the changes need to be handled in a cost-effective, minimally disruptive, timely, consistent, yet flexible way.-So how do organizations manage this process in a compliant and business savvy way?

This webinar will address key quality change management considerations of life science organizations today. Participants will learn a 4 Step Process to better manage change that includes:

People - How people contribute to the process of change control
Process - The benefits of a robust process to manage change
Procedure- How to identify the key parts of a good procedure
Profits - How a solid change control process impacts profits
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Gosia Szter
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