Pharmaceutical GMP Lead Auditor (PR325)

Do you audit your Good Manufacturing Practice (GMP) environment, either through self-inspections or via outsourced providers? Are you armed with the tools required to carry out audits to the latest guidelines?

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. 

 

 

Want to learn more about this course? 

 

Get the view from the professionals as Sue Mann and Peter Deegan discuss exactly what to expect in this on-off podcast.

 

 

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. 

Read further course information Read further course information
Duration
5 days
CPD Hours
40 hrs
Locations
  • Manchester
  • Online

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Who Should Attend

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. 

Our Lead Auditor courses are IRCA accredited, flexible and tailored to industry needs.

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. 

 

Which lead auditor course is right for me?

Key topics

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. 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Adam Slater

Adam Slater

Adam is a Pharmaceutical/Biopharmaceutical Quality Assurance professional, with over 35 years’ experience across GMP, GDP, ISO 9001, Pharmaceutical Quality Systems and auditing. Passionate about passing on his personal experience onto others, Adam is involved in the education, coaching, mentoring and training of fellow professionals at any stage of their pharmaceutical career journey.
Peter Deegan (1)

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience. Peter is adept at working with a cross-slice of people to drive a positive ‘Quality Culture’, from shopfloor to boardroom and is passionate about passing on his personal experience to others, through education, coaching, mentoring and training.
Sue Mann

Sue Mann

Sue is an experienced QP with over 40 years in the pharmaceutical industry, specialising in Good Manufacturing Practice. Since founding her consultancy in 2009, she has advised global companies on best practices and operational improvements. An inspiring trainer, Sue can break down complex topics in understandable elements and can provide appropriate training to all career levels.
What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Interactive and engaging

Very good interactive course that pushes you to learn and broaden your knowledge and abilities. The sessions were very engaging, with trainees able to ask questions throughout and open conversations encouraging participation and clarification.
Zerlina Fletcher
MeiraGTX

Opened my eyes to gaps in my knowledge.

Great course to get knowledge on auditing GMP. The information and the way it was conveyed really opened my eyes to gaps in my knowledge.
Kim Vigor
Achilles Therapeutics - Head of QC Operations

Great content and trainer

I found the content very good and the trainer - Peter was so interactive, was able to answer questions with ease and gave a lot of real life examples.
Rajbir Brana
Brana Consulting Limited - Quality Assurance Consultant

Amazing journey from just one day!

It's been an amazing journey from day one itself. We had been put through different scenarios in different situations, in real life we have been in those situations and we have been acting slightly differently prior to this particular experience, but now after learning this particular course I know that I will be acting totally differently!
Yogesh Patel
Lexon - QA Manager

100% I'd advocate this course!

100% I'd advocate (this course)! I mean, I've learned so much this week and I think I've improved myself as an auditor because of this course.
Christian Bryant
IO Biotech - Quality Manager

A well-structured and organised course

A well-structured and organised course. I learned a lot during the training and the practical sessions where especially enjoyable as I could put what I learned into practice straight away. Peter was very knowledgeable, with useful real-life experiences - he didn't read from the slides as he knew the content thoroughly.
Anonymous
UK-based Pharmaceutical Company - QA Manager

Book Your Place

Pharmaceutical GMP Lead Auditor (PR325)
30 Jun 2025
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Online
29 Sep 2025
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Manchester
24 Nov 2025
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Online
£3650 excl VAT
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Bespoke Training

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.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Learning Outcomes

By the end of the course you will: 

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    The ISO19011 'Principles of Auditing'

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    How to apply the appropriate GMP standards

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    Be able to plan, conduct, report and follow up an audit according to the audit cycle of ISO 19011 

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    Be able to create a structured audit programme 

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    Be confident in conducting an opening and closing meeting 

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    Be able to create a checklist of questions to ask 

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    Write clear, concise non-conformity reports 

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    Appreciate the importance of reporting and follow up 

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    Know how to behave to avoid conflict and gain auditee acceptance 


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Why choose RSSL?

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.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community