Design of PAT Systems for Pharmaceutical Manufacturing (PME/ME/CHE653)

The objective of this course is to provide the student with the engineering tools and knowledge required to design and deploy Process Analytical Technology (PAT) solutions in pharmaceutical drug substance and drug product manufacturing.   This course provides in-depth coverage of current PAT technologies.  At the conclusion of this course, students will understand the engineering theory, principles, and mathematics required to design and deploy these technologies in a pharmaceutical manufacturing environment in compliance with FDA and international regulations.

Topics covered include: analyzer types and principals of operation, chemometric techniques for multivariate analysis, multivariate process models, dynamic process control, and advanced pattern recognition techniques.  In addition, the course will cover the technical aspects of real-time data management and 21 CFR Part 11 compliance.

This course is primarily for engineers in the Master of Engineering program.