This course teaches you the purpose of a pharmaceutical quality management system, of pharmaceutical quality systems standards, and of internal management systems audits.
It covers the role of an auditor in planning, conducting, reporting and following up a partial pharmaceutical quality management system audit in accordance with ISO 19011. It gives you the skills to plan, conduct, report and follow up a partial audit of a pharmaceutical quality management system to establish conformance (or otherwise) against ICH Q10 and in accordance with ISO 19011.
Who is it for?
This course is for those intending to acquire the knowledge and skills to conduct partial system audits of an ICH Q10-based pharmaceutical quality management system as an Internal Auditor. This course meets part of the training requirement for IRCA certification as an Internal PQMS Auditor on the pharmaceutical auditing scheme. You will need to have first completed a CQI and IRCA Certified PQMS Foundation course if you do not have knowledge of ICH Q10.
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, e.g. 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 before starting this course