Quality Time With Oliver: Guest Michael Dominguez

A strong Container Closure Integrity Testing (CCIT) strategy starts long before a method is validated. It depends on a clear understanding of product risk, package design, acceptance criteria, and how data will support decisions throughout the product lifecycle. In this Quality Time conversation, Oliver Stauffer and Michael Dominguez explore what sponsors and testing laboratories need to align on early—from method selection and development to validation planning, statistical justification, and ongoing lifecycle management. Delve into common gaps that can lead to delays, rework, or unnecessary costs, including incomplete risk assessments and unclear expectations between partners.

For teams working in pharmaceutical quality, validation, or packaging, gain practical guidance for building CCIT programs that are scientifically sound, compliant, and built to stand up over time.