We are excited to announce the launch of our new course, providing the training and examination required to become a IRCA Accredited GMP Pharmaceutical Quality System Lead Auditor.

Following on from the successful PR330 IRCA QMS Pharmaceutical Suppliers ISO9001/PQG Lead Auditor course, RSSL is launching the new GMP Pharmaceutical Quality Systems (GMP/ICHQ10) Lead Auditor Course from Spring 2022!

“Auditing is an in-demand skillset for today’s pharmaceutical professional”, says Kasia Szymaniec, Head of Training at RSSL. “As well as formal training on international auditing standards and processes, Qualified Lead Auditors also need to be trained to plan, conduct and report audit findings against very specific reference standards, like GMP, ISO, ICH, etc. Our research has found that auditors don't often receive the right mix of standards and auditing training they need."

Our new course tackles this issue and focuses on how to audit a GMP pharmaceutical manufacturer to International GMPs and the ICH Quality guidelines of ICHQ8 (QbD), ICHQ9 (Risks) and ICHQ10 (Pharmaceutical Quality Systems). We will teach you how to set audit plans and agendas that are clear and unambiguous, lead audit meetings confidently, conduct the audit and report findings so you give professional, clear feedback to specified standards in an engaging and practical way.

All our auditing courses are IRCA certified, so successful candidates can also become ‘Pharmaceutical Lead Auditor’ certified.

As it can be hard getting practical auditing experience, especially if you are just starting in the field, we offer a highly immersive auditing experience. Not only do we give you expert tuition on the auditing and quality standards, but you get to practice leading and conducting realistic audits, where our expert tutors coach and guide you through the experience in an engaging and safe learning environment.