OPM, Compliance, Regulatory

ICH Q9 Revision 1: Updates to Enhance Quality Risk Management in the Pharmaceutical Industry and a Pathway to a Robust Contamination Control Strategy

July 18, 2024 || Cody Beaumont
 
Originally issued in 2005, ICH Q9 laid down principles and examples of tools for QRM that can be applied throughout the product lifecycle. It was a groundbreaking step towards integrating risk management into pharmaceutical quality systems, encouraging a proactive approach to potential risks, and fostering a culture of continuous improvement.…

GEP In Projects – To Practice, Or Not To Practice?

October 17, 2017 ||
 
As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following…