351f Overview of Fda's Process Analytical Technology (PAT) Process and Green Product Quality

Christopher Watts, FDA, Office of Pharmaceutical Science, CDER, Room 3548, Silverspring, MD 20993

This presentation will cover FDA agency wide initiative of Process Analytical Technology (PAT), and opportunities for "Green" quality and control within pharmaceutical processes that are registered with the FDA. Discussion will also cover the ability to perform process optimizations to registered products and processes, and utilizing process optimization to infer product quality by minimizing variations within the process.