PME 540:Validation and Regulatory Affairs in Pharmaceutical Manufacturing
An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).
PME 653:Design of PAT Systems for Pharmaceutical Manufacturing
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.
Daniel J. Wasser is a full-time Industry Professor in Mechanical Engineering and teaches graduate courses in the Pharmaceutical Manufacturing Practices Program. Prior to joining the Faculty at Stevens, Dr. Wasser was Manager of the Advanced Systems group at Foster Wheeler Pharmaceuticals and Life Sciences where his experience included modeling of pharmaceutical manufacturing facilities and validation of computer and automation systems. Prior to joining Foster Wheeler, Dr. Wasser spent eight years with Mobil Technology Corporation as an Advanced Control Engineer in the Advanced Control Automation Projects (ACAP) group and as a Research Engineer in the Computer Systems and Pilot Unit Automation Group. His areas of interest include applications of AI and expert systems technologies to manufacturing, process modeling, automation, optimization, and decision support. His expertise is in the application of these technologies to the modeling and optimization of manufacturing facilities. Dr. Wasser holds a Ph.D. in Biomedical Engineering and Mathematics from the University of North Carolina at Chapel Hill, and M.S. and B.S degrees in Chemical Engineering from Case Western Reserve University.
Research & Education
Dr. Wasser holds a Ph.D. in Biomedical Engineering and Mathematics from the University of North Carolina at Chapel Hill, and M.S. and B.S degrees in Chemical Engineering from Case Western Reserve University.
Experience & Service
Pharmaceutical Manufacturing Program
(Validation & Regulatory Affairs) Dr. Wasser is Senior Research Investigator at Bristol-Myers Squibb Pharmaceutical Research Institute. He has expertise analyzing and modeling pharmaceutical manufacturing facilities; broad experience developing novel software tools to increase capacity, improve efficiency, and reduce capital and operating costs; over ten years experience designing, implementing, validating, and deploying computer-based systems for support of manufacturing and laboratory operations.
He was previously a full-time Industry Professor in Mechanical Engineering at Stevens. He had also been Manager of the Advanced Systems Group at Foster Wheeler Pharmaceuticals and Life Sciences. He had been with Mobil Technology Corporation as an Advanced Control Engineer in the Advanced Control Automation Projects (ACAP) group and as a Research Engineer in the Computer Systems and Pilot Unit Automation Group.