Lessons Learned from FDA 483s and Warning Letters – Strengthening GMP Cleanroom Compliance in Life Sciences

Cleanrooms hosting pharmaceutical manufacturing operations are inspected at a critical scale to ensure compliance to regulatory standards. With this comes a responsibility to the manufacturing operations, quality, facility maintenance groups and the design professional team to provide a pathway to achieve regulatory approval.

We will explore critical lessons from FDA 483 observations and Warning Letters related to GMP cleanrooms in the life sciences industry. Through real-world case studies and regulatory analysis, attendees will gain a deeper understanding of common compliance failures—ranging from inadequate contamination control to flawed cleanroom design—and how to proactively address them. Our expertise emphasizes risk-based thinking, robust documentation practices, and front-end design strategies to build resilient, inspection-ready facilities.