“We get a lot of enquiries from professionals who need to audit their GMP Pharmaceutical Quality System, but don’t have a lot of auditing experience, or want to improve their auditing efficiency and effectiveness. It’s interesting that GMP requires us to audit the PQS, but doesn’t state the process or methodology on how to do it. This is what the IRCA Lead Auditor course teaches you – ‘how’ to audit. We take the proven international ISO standard on auditing and walk you through the requirements, step by step.
One of the most common concerns is ‘I need to audit, but can’t get any practice before I have to do a real audit’, which can be quite a stressful prospect. Our audit courses are highly participative – we use real-world case studies and realistic practice-audits that give you an accelerated learning experience, but in a safe learning environment. It’s great to see the journey from Day 1 to Day 5 and how the delegates become more practiced, more assured, actually able to lead an audit confidently and report clear, objective findings by the end of the week!
Today’s modern Pharmaceutical Quality System is based on ICHQ10, which brings together the structure of ISO and the tested requirements of GMP. It better defines management accountability, which is not explicit in GMP guidance. The RSSL PR325 GMP PQS Lead Auditor course teaches you how to audit not only the technical detail of the production line to GMP, but also how to audit the management intent, capability, ownership and leadership requirements that ICH Q10 stipulates.
Inspection agencies cover ICHQ10 in the scope of their inspections, so companies need to demonstrate and provide evidence that they have embedded ICHQ10 into their day to day PQS. The course also brings in the ICH Quality requirements of ICH Q8 (Quality by Design) and ICH Q9 (Risk Management) as an auditing structure.
So the big question: who would benefit from attending the RSSL PR325 GMP PQS Lead Auditor Course?
Pharmaceutical GMP professionals (QA Officers, Production Leads, QPs, Auditors) who are responsible for managing or conducting GMP self inspections, GMP QA or Quality Management System audits, GMP outsourced manufacturing audits (including Quality & Technical Agreement audits), inter-site company audits.
So the bottom line: if you want to improve your audit planning, preparation, structure, gain practice on conducting audits and reporting clear, objective findings, this is the course for you!
Explore our IRCA and CQI approved lead auditor training courses below and get in touch today for your free assessment on +44 (0)118 918 4076 or complete the contact form below or email bookings@rssl.com.