By the end of this presentation, participants will be able to describe how the SOP framework must evolve to align with ICH E6(R3) and support a risk-based, scalable quality system across an organization and/or site network. 

Participants will be able to identify key changes introduced by ICH E6(R3) that impact SOPs, recognize gaps in their current SOP language related to risk proportionality and oversight, and explain how updated SOPs strengthen inspection readiness.