Our 5-day Pharmaceutical GMP Auditor/Lead Auditor Course is registered with IRCA, the International Register of Certificated Auditors (IRCA Ref:PR325). This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses.
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 Pharmaceutical GMP Auditor/Lead Auditor 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 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”.
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, as the reviews for this course demonstrate.
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 across the globe.
If you are interested in attending our 5-day Pharmaceutical Lead Auditor course then select the link in blue in this sentance.
You can visit the IRCA web-site by clicking this link.
Please feel free to comment, especially if you are a former course delegate.
THIS ARTICLE WAS FIRST PULISHED IN 2012 AND HAS BEEN REVIEWED AND UPDATED IN JANUARY 2023.
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As a former attendee in 2011, I can recommend Inspired Pharma’s Lead Auditor training course. It was 5 days hard but enjoyable work and the Trainers were very knowledgeable and supportive at all times.
Even now 6 months on I still remember the key areas and the documentation they provided sits on my desk and used regularly!!!
Many thanks Kevin. Dominic