Being IRCA accredited is a way of demonstrating an individual’s minimum competency in auditing. Whilst most pharmaceutical companies do not insist that their internal and supplier auditors are IRCA accredited, most do expect their auditors, especially their supplier auditors, to have had some form of high-level training in how to perform audits professionally. This is critical not only because of the importance of the job that they are performing, but also as they are acting as ambassadors for their organisation. Our “Quality Management Systems Auditor/ Lead Auditor Training Course” is one such course and is Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor training course. The course covers the main principles of successfully planning, assessing, reporting and following-up of audits and is specifically tailored to train pharmaceutical auditors. The course also includes the essential skills and roles of leading a group of auditors (being a Lead Auditor).
The course covers auditing against ISO 9001, Good Manufacturing Practice and a range of pharmaceutical supplier standards, such as Active Pharmaceutical Ingredients GMP. In addition, as the course covers the general principles of auditing pharmaceutical quality management systems, our course is the only such course that also includes a detailed explanation of the requirements of both ICH Q10 “Pharmaceutical Quality System” and the FDA’s “Guidance for Industry – Quality Systems Approach to Pharmaceutical CGMP Regulations”.
The course is accredited by not only IRCA but also the Pharmaceutical Quality Group (PQG), as it covers a range of pharmaceutical supplier standards that they have been involved in the development of.
At the end of the course there is a written examination. This has a high pass mark of 70%. This is coupled with on-going continuous assessment throughout the 5-days of the course. The working days are long, usually from 8.30 am to 7.00 pm, with some (but not too much) evening work too! This does mean that a high standard has been established for successful course delegates. On successful completion of the course delegates can use their certificate as part of the IRCA and PQG auditor registration process. A range of auditor grades exist depending on experience including Internal Auditor, Auditor, Lead Auditor and Principle Auditor.
Although this sounds very serious and formal, we also bring in a great deal of humour and interest to the course which, coupled with outstanding tutors, makes for a stimulating learning experience.
In addition to becoming an international recognised pharmaceutical auditor other benefits of IRCA registration include recognised credibility, on-going continuous professional development and potentially greater employment prospects.
Further information of both IRCA and the PQG can be found at the links below. If you are interested in attending our 5-day Pharmaceutical Lead Auditor course then please visit our main web-site.
You can visit the IRCA web-site by clicking this link.
You can visit the PQG web-site by clicking this link.
We hope that you are interested. Please feel free to comment, especially if you are a former course delegate.
Find out about our course ranges