Peter Deegan:
A lead auditor is a grade of auditor set by the chartered quality institute and your name goes on to the international register for certified auditors IRCA set a minimum specification for the training courses that you have to attend rssl is now certified for both of our courses to IRCA specifications and what it means is if you pass the exam then you can put yourself on the international register and become a certified auditor.
The IRCA lead auditor course has two components really one is the training against the international ISO auditing standard and then the second part is the training against the relevant standards for your discipline. Now, IRCA are international across all industries. In the pharmaceutical industry we have both the pharmaceutical supply chain and we have GMP ICHQ10. At the core of both our courses is the international auditing standard that's the thread through the whole course and during the course we train you on the relevant standards. We don't train you on the standards you should know the standards before you come like GMP or the packaging standards or EXCiPACT or something like that we teach you how to audit against these standards through the international auditing standard itself.
Whilst both of our lead auditor courses train you on the core ISO international auditing standard our PR330 variant teaches you the standards relevant to the pharmaceutical supply chain. When you have to go and audit the supply chain it is very diverse it's not necessarily always pure GMP.
They may well be working to food grade standards or just good technical industry standards like packaging, printing etc. Well what standards do you work to? You can't just go into an audit with a GMP hat on and expect the supplier to understand to be conformant. A lot of the time there may well be ISO9001 accredited but ISO9001 isn't GMP even though we've got ICHQ10 to bridge it it's a different standard it's a different way of thinking, it's a good way of thinking, but how would you audit a supplier who's ISO9001 registered against that standard? Are you trained? Are you capable?
Well that's what PR330 does, it brings together all these diverse standards it helps you understand how to audit against them so that you can audit the supply chain and its diversity with a common thread with a clear understanding and you get the best out of the auditees themselves in my opinion.
So who should attend the PR330 supply chain lead auditor course? If you're auditing the supply chain, a diverse supply chain, excipients, packaging manufacturers, printing companies etc, that's probably the best course for you, particularly if you're auditing against ISO9001 which is our core standard for the course. That's probably the best course for you. It does cover a bit of GMP because we know that packaging companies bridge GMP in particular but it's about the supply chain and its diversity and its peripheral understanding and peripheral content to GMP.
Our next lead auditor course is the PR325 GMP pharmaceutical quality systems lead auditor. The core standard for this particular course is ICHQ10 and GMP guidances so if you are an auditor who's doing self-inspection, if you're doing internal audits if you're doing inter-site audits but against GMP requirements this is the course for you. If you're auditing suppliers but they are contract manufacturers manufacturing to your standards of GMP then this is the right course for you the supply chain is a different course remember, where it's talking about the diverse set of suppliers and different standards. This is about pure GMP.
