
This course focuses on contamination risk, one of the fastest ways to trigger regulatory concern. It examines facility design, personnel behavior, environmental monitoring, and sanitation validation from an inspector’s perspective. Participants will understand how small procedural lapses translate into cross-contamination risk and why environmental data must tell a consistent story. The emphasis is practical — how to align cleanroom discipline, flows, and monitoring programs with GMP expectations under 21 CFR 211 Subpart C. The result is stronger contamination control and fewer inspection surprises.
This is Module 3 of Practitioner Course "GMP Master Class for Life Sciences".You can either sign up only for this Module here.Or the entire course → Here