GCP Auditors: Hard to Find - Hard to Develop - Hard to Keep, 1. Criteria and Methods for Candidate Selection

Fachartikel (Teil 1/3) zur Ausbildung von QA-Auditoren im Bereich Good Clinical Practice von Rita Hattemer-Apostel, CEO, Verdandi AG

ABSTRACT:

Selection of the right candidates for Good Clinical Practice (GCP) auditing is critical for the acceptance of audit results in the future. Adequate training and qualifications are also essential to perform reliable auditing activities, to remain credible to auditees during audits, and to remain credible to senior management upon presentation of audit results. Guidance on the expectations for qualifications, with regard to educational requirements and work experience, experience in Quality Assurance (QA) and auditing, and personal attributes, can be found in ISO 10011, part 2. Means to evaluate auditor candidates and requirements for training are also considered.