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.