PME 530:Introduction to Pharmaceutical Manufacturing
Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.
PME 539:Bioprocess Technology in API Manufacturing
This course provides a broad overview of topics related to the design and operations of modern biopharmaceutical facilities. It covers process, utilities, and facility design issues, and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed.
James Dean Vogel, P.E. is the President of Process Facilities Services Incorporated, a consulting firm focused on all areas of biopharmaceutical and utility engineering and how they best support the manufacture of a product. He has more than 25 years experience in the biopharmaceutical, food and cosmetic industries. He has worked as a Director, Project Manager, and Engineer (Plant Support, Process Development, Project and Automation), with Amgen, GlaxoSmithKline, ImClone, Sanofi-Pasteur, Lipton and Avon. Mr. Vogel is an Adjunct Professor at Stevens Institute of Technology, a member of the ASME BioProcess Equipment Standard Committee, leads the Rouge and Seal Performance Task Groups, and is a member of the ISPE North American Education Committee. He is a licensed professional engineer in NJ, and he has a ME in chemical engineering from Manhattan College and a BS in biochemical engineering from Rutgers University.
Research & Education
Education
He is a licensed professional engineer in NJ, and he has a ME in Chemical Engineering from Manhattan College and a BS in BioChemical Engineering from Rutgers University.
Experience & Service
Experience
is the Principal and Owner of Process Facilities Services Incorporated, a consulting firm focused on all areas of biopharmaceutical and utility engineering and how they best support the manufacture of a product. He has more than 25 years experience in the biopharmaceutical, food and cosmetic industries. He has worked as a Director, Project Manager, and Engineer (Plant Support, Process Development, Project and Automation), with Amgen, GlaxoSmithKline, ImClone, Sanofi-Pasteur, Lipton and Avon.
Achievements & Professional Societies
Professional Societies
Mr. Vogel is a member of the ASME BioProcess Equipment Standard Committee, leads the Rouge and Seal Performance Task Groups, and is a member of the ISPE North American Education Committee.
