Omar Mmubango, a man who is proud to have learned what he knows from “the trenches of the pharmaceutical industry” (as he likes to put it) is an expert in conducting Good Clinical Practice (GCP) audits. As founder of Regulatory Affairs CMC Resources Corporation (CMC Resources), Mr Mmubango is often called upon for his expertise in assessing and evaluating how clinical trials are conducted
Quality Assurance can be periodic, quarterly or for cause. Omar Mmubango evaluation of GCP Quality Assurance and Regulatory Compliance, includes but is not limited to Trials Master Files auditing, generating lists of violations or observations, discussing such observations with supervisors, managers of laboratories or the principal director of research and recommending corrective actions and remedies.
Omar Mmubango hard won expertise is the result of years of experience in the pharmaceutical industry, learning everything from the ground up. During college, he worked as a tablet machine operator and Quality Assurance (QA) tester. His internship was spent as a research associate supporting clinical trials. After graduating, he continued his education in pharmaceuticals as a bench chemist in the Quality Control (QC) Laboratory.
Professionally, he gravitated towards regulatory compliance, verifying FDA submissions and applications. Throughout his career, he has audited and edited CMC sections of drug application files or dossiers for accuracy and completeness, before such applications were submitted to the FDA.
Omar Mmubango graduated from the University of Minnesota where he earned a B.Sc. in Chemistry as well as a BA Public Health-Affairs. He also has a B.Sc. in Agricultural Sciences—Food Science & Technology from the University of Wisconsin.
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