Course code
PR349
Duration
24 hours (indicative)

CQI and IRCA's pharmaceutical auditor training is based around good manufacturing practice (GMP) and ICH Q10. These courses are designed for people who will be auditing in the GMP environment.

This course teaches you the purpose of a pharmaceutical quality management system and of pharmaceutical quality management systems standards, and the skills to conduct and report an audit of an pharmaceutical quality management system to establish conformance (or otherwise) against ICH Q10 and in accordance with ISO 19011.

This course includes a 1-hour 40-minute 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, as a third or second-party auditor and who already have auditing competence. For those who have already completed a Lead Auditor course in another discipline, this course meets the training requirement for IRCA certification for all grades of PQMS Auditor.

Recommended prior knowledge

  • Knowledge of ISO 19011 through completion of a Lead Auditor course in another management systems discipline
  • 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, e.g. Eudralex Volume 4 or 21 CFR (pertaining to cGMPs)