Transcription of GMP Design of Pharmaceutical Facilities - ISPE Th
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GMP Design of Pharmaceutical Facilities Process Design Layouts and Flow Diagrams OSD Facilities Biopharma and Aseptic Facilities Speaker - Leonid Shnayder, , Industry Professor in Pharma manufacturing and Engineering (PME) Program at Stevens Institute of Technology Work experience: Pharmaceutical Process Development and Optimization Design of Pharma Plants (Process Engineer) Designed plants for Merck, Pfizer, Sanofi-Pasteur, Amgen etc. Teaching in the PME program at Stevens 2 Speaker - Leonid Shnayder, , Courses taught: Intro to Pharma manufacturing Validation in Pharma manufacturing GMP in Pharma Facilities Design manufacturing of Biopharmaceutical Products manufacturing and Packaging of Oral Solid Dosage Products Statistical Methods in Pharma manufacturing 3 PME Program at Stevens Institute of Technology Master of Science in Pharma manufacturing degree 10 courses (5 foundation plus 5 elective courses) All PME courses are offered in both on-campus and online delivery modes.
Current Good Manufacturing Practices (cGMP) •cGMP is a set of regulations published by the US Food and Drug Administration (FDA) •Most national and international agencies regulating
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