Frank Wackes
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Detailed Analysis
Wackes uses a comprehensive approach in his audits, ensuring that organizations not only have the necessary procedures in place but also that they are strictly adhered to. He values responsiveness to complaints and discrepancies, believing such measures are a core element of a firm's commitment to quality assurance. It is apparent he considers workforce training very vital and sees the quality control unit as an authoritative entity in ensuring quality products.
Frank Wackes is an FDA investigator that places great emphasis on quality control, procedure adherence and training. From his observations, it can be inferred that Wackes is detail-oriented and expects firms to have thorough procedures in place for complaint handling, discrepancy review, process variability control and maintaining sterility. He values workforce education, expecting employees to be trained sufficiently for their roles, and has high standards for quality control units and their authority.
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