GMP Internal Auditor

Mastering Pharmaceutical GMP Auditing with ISO 19011 Training and Practical Case Studies

This course is specifically designed to provide you with the essential skills to plan and conduct GMP self-inspection and internal audits with improved ability and confidence that will satisfy regulatory authority expectations. 


Learn how to set a risk-based annual self-inspection audit programme, plan and conduct effective self-inspection internal audits that give precise, evidence-based non-conformances to your auditee.

 

  • The course uses participative learning techniques and real-world auditing case studies to drive the learning experience.
  • Enables learners to practice realistic auditing techniques in a safe learning environment.
  • World-class tutors, who can engage learners and pay-forward their auditing experience for the next generation of auditors!

 

Interested in Internal auditing training for your team? Contact us today. 

Read further course information Read further course information
Duration
2 days
CPD Hours
14 hrs
Locations
  • Online
  • Reading (RSSL)

Who should attend?

Auditors and audit teams at the Foundation-Practitioner level of experience, who require engaging, participative learning to achieve a competence to Internal Auditor level.

 

GMP/QA professionals, responsible for managing and conducting self-inspection audits of the company’s GMP Pharmaceutical Quality System, who have yet to have any formal training, or who wish to improve or refresh their auditing skills. e.g:

 

  • QA auditors
  • GMP Professionals who have responsibility for the audit programme
  • Other GMP professionals involved in the GMP audit cycle
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Key Topics

The course covers the below topics. All sessions have practical learning exercises to help reinforce new skills and allow delegates to apply the techniques. 

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    Day 1

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    Types of audits 

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    GMP auditing standards and guidelines 

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    Setting up and managing a risk-based annual audit programme 

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    The audit cycle (planning, initiating, conducting audits) 

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    Preparing and planning for your audit 

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    Day 2

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    Checklists 

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    Auditing techniques and auditor competencies 

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    The audit process (opening meetings, the audit, closing meetings) 

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    Writing clear non-conformances

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    Audit role play

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    Writing concise audit reports and follow-up

Learning Outcomes

Our course will enable you to: 

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    Set an effective risk-based annual GMP self-inspection / internal audit programme that will satisfy the expectations of regulatory authorities

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    Plan and conduct individual audits with clear audit criteria and audit agendas 

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    Write clear non-conformances that help the auditee to meet your requirements 

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    Write effective, concise audit reports and follow up actions 

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. 

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.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

Yes, the GMP Internal 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 Internal 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 Internal 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 Internal 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.
Usually, this 2-day GMP Internal Auditor course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000.
Our online GMP Internal Auditor course begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course.

For our in-person courses, refreshments are available from 08.30am, for a 09:00am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later. 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. 
What our clients say

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

Useful for our business

It gives an amazing insight into what we as internal auditors should be looking for and what external auditors look for so should help to keep our business in compliance.
Heather Eddon
TerumoBCT Ltd.

Very worthwhile

Very worthwhile, with a really good balance of theory, practical experience from the tutor and relevant exercises and role plays.
Pauline Armstrong
TerumoBCT Ltd.

Clear and relevant to my role

An excellent course that made the audit process clear and relevant to my role, delivered in an easy-to-understand manner by an experienced trainer.
Sinead Tormey
TerumoBCT Ltd

Book Your Place

GMP Internal Auditor
04 Mar 2025
-
Online
17 Jun 2025
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Reading (RSSL)
17 Sep 2025
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Online
18 Nov 2025
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Online
£ 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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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