We will be presenting the current Good Manufacturing Practices (cGMP) per the Food and Drug Administration (FDA), and how these directives are practiced in a pharmaceutical manufacturing facility making parenterals in a Final Dosage Form (FDF). This process operation has the strictest regulations from the FDA relative to any other production areas. This is due to the direct injection of the parenterals into the human blood stream with no barriers of protection from any potential risk of contaminants or pyrogens that may cause fever or infection.
Mr. Juchnowski has recently graduated from the Cleveland State University, Washkewicz College of Engineering in the Department of Chemical and Biomedical Engineering with a Bachelor of Science in Chemical Engineering as well as having a minor in Chemistry. He has been employed at Xellia Pharmaceuticals since his graduation in June 2017. Mr. Juchnowski is also the Young Professionals Chair with the AIChE Cleveland Section. He has hosted several Trivia Challenge nights with the AIChE YPs at various locations across Cleveland. During his tenure at Xellia he has presented several topics at Cleveland State University with the Washkewicz College of Engineering during the Xellia / AIChE Lunch & Learn 12 part series on cGMP Design for Pharmaceutical Facilities. He has also participated in several panel reviews of Capstone Internship Projects on Water For Injection (WFI) spreadsheet dynamic simulations of process operations with senior students from Case Western Reserve University, Department of Chemical and Biomolecular Engineering. Mr. Juchnowski has been responsible for the complete qualification of several laboratory instruments and is gown qualified for entrance into production rooms that are Grade C and D Qualified. He also has 133 SOP training modules he is current (GMP) on each 90 days.
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