Omar MMubango and His Strict Pre-Approval Inspections
Omar MMubango is the man to look for when there is a need for pre-approval facility inspections, especially ones that are connected to the Food and Drug Administration.
He is good in reviewing and assessing the key documents related to Standard Operating Procedures (SOPs), manufacturing, Validation and Stability protocols, and also including the critical areas in the facility that are most likely to be inspected.
Omar MMubango is very much knowledgeable when it comes to the importance of carrying out pre-approval inspections. It is his mission to guarantee, along with the rationale of the inspections, that the pharmaceutical’s development, manufacturing and related control facilities are within the principles of the present Good Manufacturing Practice or GMP.
Omar MMubango makes sure that the facilities adhere to the conditions stated in the Code of Federal Regulations (CFR) parts 210, 211, 820 and 11. The CFR is the codification of the permanent rules in the Federal Register that are established by the executive departments of the Federal Government. It is within Omar MMubango’s range of duty to make sure that drug manufacturers conform to these rules of Federal regulation.
Omar MMubango does this to make sure and conclusively indicate whether or not a certain pharmaceutical is legitimate and accurate with its data in its application file. This way, the public is guaranteed of safe and effective drugs for consumption.
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Omar Mmubango Advises Companies on Regulatory Compliance and Quality Assurance SOP
With his many year in the pharmaceutical industry, Omar Mmubango has gained a unique perspective that has allowed him to advise companies on everything from FDA regulatory compliance to quality assurance standard operating procedures.
Omar Mmubango is the founder of a company called Regulatory Affairs CMC Resources Corporation (CMC Resources.) It provides short and long term resources and services related to regulatory compliance within the pharmaceutical industry.
Over the years, Omar Mmubango has gained a unique perspective which makes him the ideal person to conceptualize, review, write, and implement standard operating procedures (SOPs) utilized by the quality assurance (QA) group. By adhering to well defined SOPs, drug companies ensure that manufacturing of the FDA regulated pharmaceutical drug products, are carried out in accordance to company’s written procedures, controls and specifications at all time by all departments involved in the manufacturing process, which includes, but is not limited to every step in the supply chain.
Naturally, Omar Mmubango ensures that all QA SOPs are written and implemented in accordance with FDA and International Conference on Harmonization (ICH) regulations, standards, and guidelines.
Mr 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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Omar Mmubango Experience with the FDA DDMAC
Omar Mmubango, has spent most of his adult life in the pharmaceutical industry. His knowledge and expertise in different areas of the industry can seem arcane to the layman; but although you might have heard of him before, his work might be sitting somewhere in your medicine cabinet.
Omar Mmubango has conceptualized and implemented robust programs that determine the regulatory language used in pharmaceutical drug products intended for human consumption. He’s responsible for the wording used on Labels, Product Inserts, Cartons, as well as the specific language that goes on advertising and promotional materials for drug products.
Over the years, he’s amassed extensive experience working the USFDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). As such, he has become very well versed in all stages leading up to the approval of products and marketing material. These include:
• Pre-launch labeling and promotional materials
• Editing, auditing, reviewing and approving language on labeling and promotional materials prior to dissemination
• Editing, auditing, reviewing and approving labeling and promotional materials prior to Submission to the FDA for approval and prior dissemination to public
• Editing, auditing, reviewing and approving language on labeling and promotional materials to the FDA after approval and dissemination to public
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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