Calvin Koerner

As a former FDA Inspector, Calvin Koerner found FDA’s training and compliance evaluation tools to be lacking. There was little standardization for how inspections were completed. Inspection coverage and outcome was often dependant on the inspectors performing the inspection. Every inspector in the division had their own unique method for conducting inspections. Seldom were these individual methods written down or comprehensive.

Using the FDA’s methodology, he found himself struggling to be consistent and comprehensive. He concluded a written standard was needed to ensure compliance evaluations were completed consistently and effectively. His first attempt at developing such a standard was created on paper. The approach was to ensure all six quality systems were covered during any given inspection, instead of the two to four systems stipulated by FDA procedures.

Recognizing that there is often more than one acceptable way to meet compliance, he developed a system that prompts the evaluator to ask certain questions, instead of providing a simple compliance checklist. His inspections were immediately more comprehensive and consistent. He later introduced the standard to his immediate supervisor who suggested the tool be used as a training mechanism for new inspectors. In some cases, the standard lowered the training time for a new inspector by 50%.

After he left the FDA, he recreated and improved the standard to be more efficient and cover international regulations. Between 2006 and 2008, he transformed this compliance evaluation standard into an Access database called GMP-ACE. The new compliance evaluation database allowed real-time data capture, trend analysis, automated report writing, and many other features.


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