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 covers the purpose and benefits of a pharmaceutical quality management system, and the specific pharmaceutical quality management related requirements of ICH Q10.
Who is it for?
This course is for those requiring an introduction to ICH Q10 50001, especially those involved in the design, implementation and management of a pharmaceutical quality management system and as preparation for PQMS Auditor Training courses.
This course meets part of the training requirement for IRCA certification as an Internal PQMS Auditor on the Pharmaceutical Auditing Scheme – to be eligible for certification you'll also need to complete a CQI and IRCA Certified Internal PQMS Auditor Training course after this one.
Recommended prior knowledge
- Plan do check act (PDCA) framework
- The core elements of a management system and the interrelationship between management responsibility, policy, planning, implementation, measurement, review and continual improvement
A basic knowledge of the requirements of the relevant GxP legislation and guidance for the discipline in which they operate, 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 one year's experience working in a GxP environment or a combination of both before starting this course.