Process Analytical Technology (PAT) in Pharmaceutical Operations (PME551)

This course provides an overview of PAT applications in pharmaceutical operations.  At the conclusion of the course, students will understand the PAT life cycle, be able to identify PAT applications likely to yield positive benefit, understand issues of organizing and managing a PAT project and integrating the principles of Quality by Design into the effort (i.e. design control, facility and equipment control, production and process control, and material control).  Students will also understand the principles of integrating PAT application projects with the six-sigma approach to process improvement:  Define, Measure, Analyze, Improve and Control (DMAIC). Topics covered include:  PAT applications, risk analysis/risk management, project management issues (integrating PAT into process and product development, technology transfer to manufacturing, change management, etc.), and the PAT system project life cycle.  Examples of PAT impact on workflow, productivity, process variability and product quality will be discussed. Course is primarily for non-engineers in the M.S. program. Prerequisite: PME 530.