Pharmaceutical Manufacturing



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Pharmaceutical Manufacturing Graduate Certificates

Fall 2009

The Pharmaceutical Manufacturing Engineering (PME) Program at the Stevens Institute of Technology currently offers five 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.

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 Introduction to Pharmaceutical Manufacturing

PME 531 Process Safety Management in Pharmaceutical Manufacturing *

PME 535 GMPs in Pharmaceutical Facility Design

PME 538 Chemical Technology Processes in Pharmaceutical Manufacturing

PME 539 Bioprocess Technology in Pharmaceutical Manufacturing

PME 540 Validation & Regulatory Affairs

PME 541 Validation of Computerized Systems

PME 542 Regulation & Compliance in the Pharmaceutical Industry (MGT 684) *

PME 551 Process Analytical Technology (PAT) in Pharmaceutical Operations

PME 560 Quality in Pharmaceutical Manufacturing

PME 600 Engineering Economics and Cost Analysis (EM 600) *

PME 609 Introduction to Project Management [section WP] (MGT 609) *

PME 621 Pharmaceutical Mixing (CHE 621) **

PME 628 Pharmaceutical Finishing & Packaging - Solid Dosage

PME 639 Modeling & Simulation of Pharmaceutical Manufacturing Systems **

PME 640 Contemporary Concepts in Validation

PME 643 Design and Management of Aseptic Pharmaceutical Manufacturing Processes

PME 646 Biopharm Facilities Design

PME 647 Environmental Systems (HVAC) in Healthcare Manufacturing

PME 649 Design of Water, Steam, & CIP Utility Systems

PME 653 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

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