Abstract
Quality education in the regulatory field depends on the capacity to communicate not only the rules and the standards but also the principles underlying their rationales. It is, therefore, necessary to have assimilated rules and principles to examine how quality is generated, produced, and controlled, bearing in mind that total quality corresponds to the quality of the process through which the result is obtained.
The characteristics of the processes leading to final products in chemistry, manufacture, control (CMC), pharmacotoxicology, and the clinical part of the registration dossier are examined and considered in a context of total quality management. The educational approach in the regulatory field must be characterized by interdisciplinarity and the capacity to highlight the interactions of diverse and highly specialized contributions.
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