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In 2006, Calvin Koerner left the FDA and started Intermediary Quality Auditing to address several observed GMP and Regulatory needs within the pharmaceutical, biotech, tissue, blood, and device industry. His combined Industry and Government experiences have provided a unique perspective in creating and developing innovative tools and services to better serve these industries.

Calvin Koerner obtained his start in the pharmaceutical / biotech industry as a Validation Specialist after graduating with a biology teaching degree. After switching to a Quality Oversight role, he completed a Masters of Science degree specializing in Quality Assurance and Regulatory Affairs. During his industry tenure, he gained vast experience with various product types and processing methods including: small molecule, blood derivatives, vaccines, monoclonal antibody, and animal derivatives. Within the corporate environment, he became adept at creating strategies to meet desired business objectives, while addressing regulatory requirements. His experiences with cross functional teams in achieving project objectives have proven to be an asset.

In 2002, Calvin Koerner had the privilege of joining the FDA as a CMC Reviewer and Pre-Approval Inspector. Within a year of commencing government service, he was elevated to Senior Reviewer and Lead Inspector. In addition to this role, he was often requested to provide intra-agency training / mentoring and feedback to regulatory inquiries from Industry. After demonstrating advance technical skills and regulatory knowledge, he was requested to serve as Acting Branch Chief. During his FDA tenure, he expanded his product portfolio and knowledge to included in-vitro device and cell / tissue manufacturing. He has received numerous awards for outstanding service from the FDA.

Since founding I.Q. Auditing, Calvin Koerner’s experience and knowledge have expanded greatly beyond the U.S. Regulatory arena. All of I.Q. Auditing’s tools and services incorporate European, Canadian, U.S., and Japanese CGMP regulations.

I.Q. Auditing works with a network of consultants when a mock inspection or large project requires additional personnel.

 

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