Defining Optimal Operating Regions in Process Validation (2026-US-30MP-2965)

Process validation, such as Quality by Design (QbD) approaches, relies on designed experiments to understand process behavior and define optimal operating regions. These efforts commonly progress from scouting and screening studies to response surface methods, with regulated industries requiring clear definition of Proven Acceptable Ranges (PARs) for Critical Process Parameters (CPPs).

At Gore, we apply JMP as our enterprise analytics platform to support process validation across a diverse set of manufacturing environments and industrial applications – including medical device, pharmaceutical, automotive, aerospace, and apparel. JMP’s modeling, profiling, and simulation capabilities enable us to define and clearly communicate PARs that support high confidence in producing conforming product in complex, real‑world conditions.

This presentation features live JMP demonstrations addressing challenges, such as worst‑case design space evaluation, diagnostics for complex mixed models, and specifications on multiple devices per experimental unit. The resulting visualizations in JMP can tell a compelling story to team members across leadership, engineering, and manufacturing to inform decision making for the business.