Tag Archive: ATMPs

The Readiness Stage of Technology Transfer 

January 15, 2024 || Robert Ossig
During a pharmaceutical technology transfer (TT) project, the Readiness Stage plays a pivotal role by establishing the groundwork for a successful transition. This phase involves meticulous planning, coordination, and execution of key activities across various functions, each contributing to the readiness of the Receiving Unit (RU) for Process Performance Qualification…

The Future of FDA Regulatory Inspections:   

December 27, 2023 || Connie Leech
The Office of Regulatory Affairs (ORA) at the U.S. Food and Drug Administration (FDA) is currently buzzing with activity and exciting developments. Here’s a snapshot of what happened in the last 24 months:  In June 2023, the FDA updated its new model for the Office of Regulatory Affairs (ORA). This…