Pharmaceutical GMP Lead Auditor (PR325)
Our Comprehensive GMP PQS Lead Auditor Training equips you with the essential skills to plan and conduct audits with improved ability and confidence, ensuring you know how to correctly assess conformance to the correct GMP and ICH Quality guidelines.
This course covers the whole audit cycle, from setting the annual audit programme, through to planning, conducting, reporting and follow-up of audits to cGMPs, ICHQ10, API and excipient standards and guidelines. Delegates will be assessed through practical tasks, using real world case studies and mock audits covering internal audits and self-inspections, external outsourced GMP supplier audits and a range of dosage forms.
We are proud to have trained hundreds of auditors from across the world. With a pass rate over 90% (the IRCA average is 76%), our tutors are world-class auditors in their field, who are passionate about transferring their skills to the next generation of auditors.
What's included in the course cost?
Course and supporting materials (available in digital or hardcopy)
Course attendance certificate
Accommodation and all catering (this is unique to RSSL)
Full access to our expert tutor’s support during course times
Examination fees
Free 1-2-1 feedback session (on day five)
Interested in GMP Lead Auditor training for your team? Contact us today.
This course is designed for those looking to acquire the knowledge and skills to audit a GMP Pharmaceutical Quality System, including ICHQ10. This includes the ability to conduct effective self-inspection internal audits, as well as external audit programmes, significantly contributing to GMP-assurance obligations.
Anyone looking to attend this course should be equipped with good working knowledge of GMP with ideally 3-5 years’ experience working in a GMP environment.
We offer a wide range of delivery options, including face-to-face (residential), online via instructor-led blended learning or in-house through tailored programmes for the whole team. To maintain the quality and attention one would expect of our training, course attendee numbers are limited to 12.
Delegates are assessed throughout the course, concluding with an examination set by IRCA. Successful course participation and passing the IRCA examination will allow you to apply for IRCA Lead Auditor registration, giving your CV and profile a step-up within the industry. In the unlikely event you do not pass the examination, RSSL will continue to provide support, and you will be able to re-sit the examination at the next available date.
Course pre-requisites
To comply with the IRCA certification rules, a tutor will conduct a short interview with each potential attendee prior to the course. This will help convey the level of participation expected during the course as well as running through the required pre-reading and pre-course preparation. This meeting also gives the opportunity for delegates to discuss their personal learning objectives, ensuring that we meet your needs.
The course covers the following topics for either face to face or Virtual Instructor Led Training (VILT) methods. All sessions include practical exercises, real world case-studies and audits with highly participative proven learning techniques.
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
| Yes, the GMP Lead Auditor course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. |
| Places will be available for you to book unless it states ‘Full’ next to your chosen GMP Lead Auditor course date. When this occurs, we operate a waiting list service. |
| Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. |
| You will need to first register yourself on our booking system by selecting the GMP Lead Auditor course date that you wish to book your colleagues onto, then: - Add the number of people you wish to book onto the course - Register yourself as the booker and complete the fields accordingly - Add the details of those you wish to book for - Complete your order. |
| You will receive an automated email confirming your booking details for the GMP Lead Auditor course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included. |
Yes, this IRCA GMP Lead Auditor course is available in-person or virtually on the Adobe Connect training platform. If a venue is listed against your preferred course date, then this course is scheduled as an in-person session.
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
| Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system. |
| Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. |
| Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. |
| Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email. |
| As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage. Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test. |
| Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees. All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK. |
| Our classroom courses are fully catered, and we provide all refreshments. If you have any special dietary requirements, please enter these into the ‘dietary requirements’ field when creating your account. Our virtual tutor-led courses will include a 45-minute lunch break. |
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
By the end of the course you will:
The ISO19011 'Principles of Auditing'
How to apply the appropriate GMP standards
Be able to plan, conduct, report and follow up an audit according to the audit cycle of ISO 19011
Be able to create a structured audit programme
Be confident in conducting an opening and closing meeting
Be able to create a checklist of questions to ask
Write clear, concise non-conformity reports
Appreciate the importance of reporting and follow up
Know how to behave to avoid conflict and gain auditee acceptance
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
