Spring 2010
The Pharmaceutical Manufacturing Engineering (PME) Program at the Stevens Institute of Technology currently offers six Graduate Certificates, in addition to the Master’s Degree in Pharmaceutical Manufacturing, to satisfy specialty needs within the industry.
One Graduate Certificate (GC) is more general, and the others each address specialty areas within the process and equipment engineering aspects of pharmaceutical manufacturing. Each GC has three required courses and a technical elective course, and is described as follows:
1.
Pharmaceutical Manufacturing Practices (PMP) , an introductory overview of the industry, touching on all basic manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry, and one technical elective. This is the best sequence for individuals relatively unfamiliar with the industry.
Courses: PME 530, 535, 540; and 538 or 628 or other technical elective.
2.
Validation & Regulatory Affairs (VRA) , for individuals who work or aspire to work in the validation part of the industry, to test and confirm that equipment and processes meet all specifications. More detailed studies of the general concepts, specific applications to computerized systems, compliance issues, and quality aspects of manufacturing.
Courses: PME 540, 640, and two out of 541, 542, 560. (Revised)
3.
Design of Pharm. Facilities (DPF) , for individuals who work in engineering companies, or who deal with facilities issues; covers overall facilities design issues, the more detailed design of water systems and HVAC systems, and the challenges required in biopharm facility design.
Courses: PME 535,649, 647; and 646.
4.
Project Engineering in Pharm. Mfg. (PEPM) , for project engineers and project managers, and those aspiring to these positions in the pharm industry. Includes the overall discipline view of facilities design, a formal introduction to project management concepts, specific implementation concepts for sterile facilities, and the newer PAT concepts.
Courses: PME 535, 609, 643; and 551 or 653.
5.
Bioprocess Systems in Pharm. Mfg. (BSPM) , for individuals who address biopharm manufacturing technical issues. Includes overall facilities issues, biotechnology processes, specific biopharm facilities design concepts, and sterile facilities approaches.
Courses: PME 535, 539, 646; and 643.
6.
Medical Devices Design and Manufacturing (MDDM), for individuals interested in the technical challenges of this rapidly growing area. Includes the manufacturing of medical devices, specifically manufacturing processes, facilities design issues, validation and regulatory affairs concepts which drive the industry, and design of BioMEMS and electromechanical devices.
Courses: PME 580, 660, and others in development (NEW!)
1

Generally, the courses noted are the ones required for the GC. There may be another course that may be substituted for the last one, but such a course must be relevant to the certificate being earned, and must be approved in advance on a Study Plan. Such a course is intended to be a technical elective, and not a management elective.
All GCs can be credited towards a Master’s Degree in Pharmaceutical Manufacturing.
The list of current courses in the PME program follows:
Course No. Course Title
PME 530
PME 531
Introduction to Pharmaceutical Manufacturing
Process Safety Management in Pharmaceutical Manufacturing *
PME 535 GMPs in Pharmaceutical Facility Design
PME 537 Sustainable Design for Bio-Pharma Facilities (NEW!)
PME 538
PME 539
Chemical Technology Processes in Pharmaceutical Manufacturing
Bioprocess Technology in Pharmaceutical Manufacturing
PME 540
PME 541
PME 542
PME 551
Validation & Regulatory Affairs
Validation of Computerized Systems
Regulation & Compliance in the Pharmaceutical Industry (MGT 684) *
Process Analytical Technology (PAT) in Pharmaceutical Operations
PME 560 Quality in Pharmaceutical Manufacturing
PME 580 Medical Device Design and Technology (NEW!)
PME 600
PME 609
PME 621
PME 628
PME 639
Engineering Economics and Cost Analysis (EM 600) *
Introduction to Project Management [section WP] (MGT 609) *
Pharmaceutical Mixing (CHE 621) **
Pharmaceutical Finishing & Packaging - Solid Dosage
Modeling & Simulation of Pharmaceutical Manufacturing Systems **
PME 640
PME 643
PME 646
PME 647
Contemporary Concepts in Validation
Design and Management of Aseptic Pharmaceutical Manufacturing Processes
Biopharm Facilities Design
Environmental Systems (HVAC) in Healthcare Manufacturing
PME 649
PME 653
Design of Water, Steam, & CIP Utility Systems
Design of Process Analytical Technology Systems for Pharmaceutical Mfg. **
PME 660 Medical Devices Manufacturing
* PME management courses; ** For engineering students
Course descriptions can be found at http://www.stevens.edu/ses/me/Graduate/pharma/index.html
2