Course Overview

This 5-day Pharmaceutical GMP Auditor/Lead Auditor Course covers how to effectively plan, perform, report and follow-up pharmaceutical audits against a range of pharmaceutical standards, including GMP, API GMP, Excipient GMP, Packaging Supplier Standards and GDP.

The course is registered with IRCA, so you can become an internationally registered pharmaceutical auditor. 

The course is aimed at internal and supplier auditors, along with key personnel involved in Quality Assurance and Quality Management Systems. 

The course will also benefit those involved in the purchasing of incoming materials and individuals who look after the whole supply chain. Additionally, the course is ideal for trainee Qualified Persons (QPs) as well as existing auditors who have had no formal auditor training.  

The course may be used as part of Continuous Professional Development (CPD) of many quality professionals.



What's Included

It is recommended that attending delegates have an appreciation of the standards covered during the course, but this is not essential.

This includes knowledge of the requirements of ICH Q10 (plus ICH Q8 and ICH Q9) and a basic knowledge of Eudralex Volume 4 (European Union GMP).

Delegates are assessed by continuous assessment throughout the course and a final examination.

  • ~ Full tutor support and access during course times.
    ~ Course attendance certificate.
    ~ Course folder containing copies of slides.

  • ~ Five day course
    ~ 09.00 – 17.30 (UK time)
    ~ Two 15 minute breaks, 45 minute lunch.

  • ~ A link will be sent for online training.
    ~ Along with joining instructions.
    ~ Active participation is expected.