Quality Assessment Lead U.S. Food and Drug Administration Silver Spring, Maryland
Modeling is a powerful tool for manufacturing process development and routine control. Various models can be created for a single process, varying from local models for individual unit operations/steps, to the overall model that describes the entire process. These models will require different approaches to development, validation, and life-cycle maintenance. The presentation will address regulatory aspects of various process models in drug product manufacturing.
Describe the common modeling and analytics approaches used in developing robust manufacturing process of oral solid dosage forms, including both batch and continuous process.
Demonstrate different roles played by process models and empirical models in developing and deploying batch vs. continuous process and with respect to their implications for RTRt.
Define what the best practice could be in future, regarding the synergetic use of both process models and empirical models for a robust manufacturing process.