GCP Auditors: Hard to Find - Hard to Develop - Hard to Keep, 3. Continuous Education and Further Development

Fachartikel (Teil 3/3) zur Ausbildung von QA-Auditoren im Bereich Good Clinical Practice von Rita Hattemer-Apostel, CEO, Verdandi AG
ABSTRACT:

Clinical research is a dynamic and constantly changing discipline. Continuous education of good clinical practice (GCP) auditors is required to guarantee consistent and dependable audit results during their careers. Ongoing training should strive to increase the auditor's capabilities and skills, even beyond GCP. This should not only maintain the quality assurance (QA) auditor in a position to conduct audits according to state-of-the-art methodologies and regulations, but also promote her/his further career development. To be fit for purpose does not only characterize processes meeting defined requirements, but also implies that QA auditors must be continuously trained (hence, be fit) to perform high-quality audit services (hence, the purpose).