If you're an engineer or a healthcare worker in related industries, this multi-disciplinary online graduate program in pharmaceutical manufacturing engineering provides you with essential skills. Focus on manufacturing and facilities, keeping in mind the industry's regulatory requirements. Learn about U.S. Food and Drug Administration (FDA) regulatory requirements, including Good Manufacturing Practice (GMP) and Quality Systems Regulations (QSR). Emerge as an expert, ready to meet the major demands that the pharmaceutical industry faces in the twenty-first century.

Pharmaceutical Manufacturing Practices Certificate Program (4 Courses) 

Introduction to Pharmaceutical Manufacturing PME530WS	Fall 2004
Validation and Regulatory Affairs in Pharmaceutical Manufacturing PME540WS	Fall 2004
Pharmaceutical Finishing and Packaging Systems PME628WS	Fall 2004
Good Manufacturing Practice in Pharmaceutical Facilities Design PME535WS	Spring 2005

Credits	3 credits per Course/12 credits per Certificate ASME members can take advantage of the 10% discount off of tuition
Tuition/credit	$ 825/credit
Fall 2004 starting date	September 7, 2004
Fall 2004 ending date	December 13, 2004
Application	Apply
Phone	201-216-5084, 800-496-4935
Fax	201-216-8044
Email	webcampus@stevens-tech.edu
Mail	WebCampus.Stevens The Graduate School Stevens Institute of Technology Castle Point on the Hudson Hoboken, NJ 07030 United States of America

Validation and Regulatory Affairs in Pharmaceutical Manufacturing (PME540WS)
Faculty: Dan WasserAn 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).

Pharmaceutical Finishing and Packaging Systems (PME628WS)
Faculty: R. KellerUnderstand finishing and packaging systems in the pharmaceutical and health-related industries. Explore unit operations, such as blending, granulating, compressing, branding, and coating for capsules and tablets. Learn about packaging equipment for tablet and capsule counting, capping, security sealing, banding, labeling, cartoning, and blister packing. Master the use of design tools for selection, specification, line layout, and computer simulation. Become expert at project-based design for typical packaging of either solid-dose or liquid products. Practice CAD and computer simulation techniques for projects requiring analysis of material flow, space constraints, operator needs, and equipment selection. Learn how to document equipment specifications, capital expenditures, purchases, test plans, and validation requirements.        

Good Manufacturing Practice in Pharmaceutical Facilities Design (PME535WS)
Faculty: Nicholas PhillipsBecome familiar with current Good Manufacturing Practice (GMP) compliance in the design of pharmaceutical and biopharmaceutical facilities. Uncover issues related in process, material, and people flow. Learn about the special needs of the pharmaceutical industry for architecture and engineering, including mechanical, industrial, electrical and computer systems. Study specialized requirements for HVAC, automation, and bio-safety. Develop effective written procedures to document highly complex yet safe processes. Learn about clinical phases I, II, III and their effect on plant design. Find out how to defend products against contamination.