CMC Session: Continuing Discussion: Statistical Considerations for Continuous Manufacturing Processes
*Celia N. Cruz, CDER/Office of Pharmaceutical Science/IO 


This is a continuation of the session from last year, extending discussion around the evolving topic of statistical considerations for continuous manufacturing. In addition to presenting an update on the current FDA perspective on this topic, the session will introduce perspective and experience from a non-pharmaceutical industry in which continuous manufacturing processes have been successfully used for many years.