It is another one of Omar MMubango specializations to review and approve Operational Qualification (OQ), Installation Qualification (IQ) and Process Qualification (PQ) validation protocols.
These are also just some of his skills when it comes to regulatory affairs and new drug applications. Indeed, Omar MMubango has a lot of skills and know-how when it comes to making sure that manufacturers do not sell any hazardous material to the public.
The Installation Qualification verifies that the materials and equipment used, inclusive with its ancillary systems and sub-systems, are all conforming to the installation qualifications. Meanwhile, the Operational Qualification goes with an interactive SOP as its prefixed document. Another is the PQ, which is executed after a thriving completion of the Installation Qualification and Operational Qualification execution. It is Omar MMubango’s skill to approve the aforementioned qualifications.
Omar MMubango, though he is already an expert in the area, is privileged to be working with validation teams. This way, the space for error in validating is minimized. The validation team will submit acceptance criteria for Omar MMubango to evaluate to see if changes should be made. After evaluating, and finding out that the criteria were thoroughly adhered to, then there will be no problem with the Food and Drug Administration.
Omar Mmubango knows the pharmaceutical industry like the back of his hand. Having gained invaluable experience from working “in the trenches of the pharmaceutical industry,” Mr Mmubango is uniquely qualified to provide advice to companies with regard to regulatory compliance and pre-approval inspections for their facilities.
Omar Mmubango is widely considered an expert in the FDA’s pre-approval facility inspections. Among others, his responsibilities include preparing key documents such as SOPs, Validation and Stability protocols, determining batch and manufacturing procedures, and identifying key or critical areas in the facility likely to be inspected. He also advises key company departments and personnel or heads of key departments on the regulatory standards expected by the FDA and how best to comply with those requirements.
Omar Mmubango is also the founder of Regulatory Affairs CMC Resources Corporation (CMC Resources); and is often called upon for his expertise in assessing and evaluating how clinical trials are conducted.
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.
Omar Mmubango is considered and expert at regulatory compliance for the USFDA. Over the years, he’s acquired considerable expertise in matters related to verifying whether or not pharmaceutical companies and manufacturers are strictly adhering to commitments they’ve made to the USFDA regarding their drug applications.
A professional through an through, Omar Mmubango uses his expertise to determine whether drug companies have made any changes to their drug formula, manufacturing process, or labeling which could have a bearing on the safety and effectiveness of drug products already approved by the FDA for the US market. He also ensures that any such changes made by drug companies are immediately reported to the FDA.
Omar Mmubango hard won expertise is the result of years spent in the trenches of the pharmaceutical industry, learning everything from the ground up. During his college years, he worked as a tablet machine operator and Quality Assurance (QA) tester. His internship was spent as a research associate supporting clinical trials. After college, he continued his education in pharmaceuticals as a bench chemist in the Quality Control (QC) Laboratory.
Professionally, he’s been a senior quality assurance auditor, responsible for, among other things: reviewing batch records, validation protocols, standard operating procedures, and internal controls checklists. He gravitated towards regulatory compliance, verifying FDA submissions and applications. In this capacity, he audits and edits CMC sections of drug application files or dossiers for accuracy and completeness, before such applications are 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.