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…
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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…
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