In recent years, there have been published reports of an increase in Food and Drug Administration (FDA) inspectional observations associated with training deficiencies. Specifically, these inspectional observations have focused on training related to the quality system requirement that manufacturers "shall" have personnel with the necessary background, education, experience, and training to assure that all required activities are correctly performed in accordance with the governing requirements.

This is actually not a new issue, but rather one to which the FDA is paying closer attention. The FDA has long maintained that a key aspect of a compliant quality system is management’s responsibility to provide adequate resources—including the assignment of trained personnel—for management, performance of work, and assessment activities, including quality audits to meet the requirements of the quality system regulation.

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