Kenneth Muhvich, PhD Micro-Reliance, LLC

Ken Muhvich is the Principal Consultant for Micro-Reliance LLC, which he formed in 2002. Micro-Reliance specializes in Sterility Assurance and Microbial Quality Consulting. He has more than 35 years experience as a microbiologist. He frequently conducts audits of sterile product manufacturing facilities, including their microbiology laboratories. He is often asked to provide advice regarding investigations into product sterility failures. From 1992 to 1997 Ken was a Review Microbiologist at the U.S. Food & Drug Administration’s Office of Generic Drugs. While at the FDA, he performed more than six hundred sterility assurance reviews. He is a recognized expert in aseptic processing of sterile drug products. He holds a Bachelors degree in Health Science from the University of Delaware. He holds a Masters degree in Medical Microbiology from West Virginia University. He supervised the Clinical Microbiology Laboratory at Sinai Hospital in Baltimore, Maryland for a decade. He holds a Doctor of Philosophy degree in Experimental Pathology from the University of Maryland. He is currently Co-leader of the Parenteral Drug Association Task Force that is writing the Technical Report for Blow/Fill/Seal technology.