Course code
PR325
Duration
40 hours (indicative)

This course teaches you the purpose of a pharmaceutical quality management system, of pharmaceutical quality systems standards, of management system audits in the supply chain.

It covers the role of an auditor to plan, conduct, report and follow up an audit of a pharmaceutical quality management system audit in accordance with ISO 19011. It gives you the skills to plan, conduct, report and follow up an audit of a pharmaceutical quality management system to establish conformance (or otherwise) against ICH Q10 and in accordance with ISO 19011.

This course includes a 2-hour written examination.

Who is it for?

This course is for those intending to acquire the knowledge and skills to audit a whole ICH Q10-based pharmaceutical quality management system, either as a third or second-party auditor. This course meets the training requirement for IRCA certification for all grades of PQMS Auditor.

Recommended prior knowledge

  • Knowledge of the requirements of ICH Q10 (plus ICH Q8 and ICH Q9)
  • A basic knowledge of the requirements of the relevant GxP legislation and guidance for the discipline in which they will audit, eg Eudralex Volume 4 or 21 CFR (pertaining to cGMPs). GxP knowledge would typically be obtained by a four-day (30+ hours) training course or two years' experience working in a GxP environment, or a combination of both