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Europe's leading and most successful IRCA registered Pharmaceutical GMP Auditor/Lead Auditor Course

Do you want to perform audits for your organisation?  If so, you are an ambassador for your company, and so it is essential that you perform these audits professionally.

Our 5-day Pharmaceutical GMP Auditor/ Lead Auditor training course covers how to effectively plan, perform, report and follow-up pharmaceutical audits against a range of pharmaceutical standards, including GMP, API GMP, Excipient GMP, Packaging Supplier Standards and GDP.

Plus, the course is registered with IRCA, so you can become an internationally registered pharmaceutical auditor. 

Course DatesKey Information

Europe’s leading and most successful IRCA registered Pharmaceutical GMP Auditor/Lead Auditor Course

Do you want to perform audits for your organisation?  If so, you are an ambassador for your company, and so it is essential that you perform these audits professionally.  Our 5-day Pharmaceutical GMP Auditor/ Lead Auditor training course covers how to effectively plan, perform, report and follow-up pharmaceutical audits against a range of pharmaceutical standards, including GMP, API GMP, Excipient GMP, Packaging Supplier Standards and GDP.

GMP Training accreditted coursePlus, the course is registered with IRCA, so you can become an internationally registered pharmaceutical auditor. Our final examination success rate is currently 95%. The IRCA average success rate for standard Lead Auditor courses is 76.5%.

Why not attend this highly praised and prestigious course, which has been used for training over 1,000 pharmaceutical auditors over the past 10 years? Attend our 5-day Pharmaceutical GMP Auditor/Lead Auditor course and you will leave with the knowledge, skills and enthusiasm to achieve these goals.

Training to inspire you

Our courses receive fantastic reviews. Some ‘nuggets’ from our reviews.io website are shown opposite/below. Use the chevrons under the ‘nugget’ to navigate all of them. See the full quotes further down this page.

Make a Booking

The course is available on the following dates and will be delivered EITHER in a traditional classroom venue (in 2022) OR using our proven ‘live online interactive’ courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. 

The dates for the course should appear above this text. If there are no dates please refresh this screen. This normally sorts out this little glitch (which we hope to fix shortly). If the dates still do not appear then visit this page and book from there.

IN HOUSE COURSES - this course can also be delivered on your site or using our 'live online interactive' courseware on a date to suit you. If you are interested please contact us at  info@inspiredpharma.com . To see our full range of in-house courses and customisation and delivery method options please visit this page.

Classroom Venue Details

To find out the details of our classroom venues select the buildings icon.

Booking details

Select the tabs below to find out all the details you need to know to make a booking:

Course cost

£3295 (approximately €3700) plus VAT. Course will be charged in GB pounds.

Delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.

What's included in cost

The cost includes:

  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate.
  • Full tutor support and access during course times.
  • Additional support given where needed.
  • Your own personnel copies of the main standards covered during the course, including: EU GMP • USA GMP • API GMP • Excipient GMP • Good Distribution Practice • Good Distribution Practice for active ingredients • ICH Q9 and 10
  • Examination fees.
  • Free examination re-sit and additional coaching (if needed) on the next public course.
  • Our final examination success rate is currently 95%. The IRCA average success rate for standard Lead Auditor courses is 76.5%. 

Plus on Classroom courses refreshments and lunch are provided during course times.

Not Included on Classroom courses: Accommodation costs – which need to be booked directly with the hotel – see venue details.

Payment

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

If you plan to pay by credit card then you should first look at this helpful information.

Alternatively, if you want to discuss any aspect of this  training course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

Based Outside the UK?

If so, be sure to pick the ‘Tax Exempt’ options in the payment method list when you are  making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.

Group Bookings - discounts of up to 50%

Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.

Classroom venues and Live Online

Due to the uncertainties involved in travel at the moment most of our public courses are being delivered using our proven ‘live online interactive’ technology. Delegate feedback from these courses has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times. In 2022 we are looking to also offer traditional classroom courses – see the Course Dates panel for details. For venue and accommodation cost details click here. 

N.B we reserve the option to switch our classroom courses to our ‘liveonline interactive’ format if this is no longer a viable and safe delivery method.

Academy Skills Library

When a delegate completes their Course Feedback form they will be offered  free unlimited access to nearly 400 self-paced online courses for 6 months. For more details select the icon.

Key Course Information

Is this course right for you?

Click on the tabs below to find out if you will benefit from attending this course:

Who will the course benefit?

Our GMP Auditor/Lead Auditor Course is aimed at internal and supplier auditors along with key personnel involved in Quality Assurance and Quality Management Systems. The course will also benefit those involved in the purchasing of incoming materials and individuals who look after the whole supply chain. Additionally, the course is ideal for trainee Qualified Persons (QPs) as well as existing auditors who have had no formal auditor training.  The course may be used as part of Continual Professional Development (CPD) of many quality professionals.

So that we can give the delegates the right amount of time and attention – we limit this course to a maximum of 10 delegates.

Pre-course knowledge:

It is recommended that attending delegates have an appreciation of the standards covered during the course, but this is not essential. This includes knowledge of the requirements of ICH Q10 (plus ICH Q8 and ICH Q9) and a basic knowledge of Eudralex Volume 4 (European Union GMP).

Course accreditation:

Our Pharmaceutical GMP Auditor/Lead Auditor Course is approved by IRCA (The International Register for Certificated Auditors) and meets their current PQMS Auditor/ Lead Auditor training course requirements. On successful completion of this course delegates may begin registration with IRCA as an internationally recognised auditor of Pharmaceutical Quality Management Systems (PQMS). IRCA course reference number – A17632.

Assessment:

Delegates are assessed by continuous assessment throughout the course and a final examination. Our final examination success rate is currently 95%. The IRCA average success rate for standard Lead Auditor courses is 76.5%. In the event of failing the final examination, we offer free support and a free examination re-sit.

Course Times:

This is an intensive course with assessments throughout. The timings are as follows:

On Line Interactive course:

Pre-course work: Around 3-4 hours work done the week before the course and undertaken  using our online Academy.

Days 1 – 3:

09.00 – 17.30 consisting of 6 live online sessions lasting from 15 minutes to 90 minutes with breaks in between of 15 to 60 minutes plus an hour of evening work on a self-study basis

Day 4:

09.00 – 17.30 consisting of 6 live online sessions lasting from 15 minutes to 90 minutes with breaks in between of 15 to 60 minutes plus 90 minutes of evening work on a self-study basis

Day 5:

09.00 – 17.30 consisting of 5 live online sessions lasting from 45 minutes to 120 minutes with breaks in between of 15 to 60 minutes

Examination: taken after the course, normally within a 2 to 3 week period. See below for more details.

Classroom course:

Day 1: 09.00 – 18.45

Days 2, 3 & 4: 08.30 – 18.30

Day 5: 08.30 – 16.30 (includes final examination)
There is also approximately 1 hour of evening work each evening.

Examination:

Online course:

120 minutes, with an additional 20% of the time allowed (24 minutes) if English is not first language.  An additional 30% of the time (36 minutes) is allowed for specific disabilities. Exams to be invigilated online on a one-to-one basis, or small group if from the same organisation, at agreed dates within 8 weeks of taking the course.  The exams will be recorded.

Classroom Course:

The examination takes place on the afternoon of the final day and under strict exam conditions. See above for timings.

Course Details

Click on the tabs below for more details on the content of the course:

Course Overview

This is a unique training course for pharmaceutical auditors who will audit against pharmaceutical Good Manufacturing Practice (GMP) and/ or audit suppliers to pharmaceutical manufacturing sites.  The course trains auditors how to professionally plan, perform, report and follow-up internal and supplier audits and is set in a pharmaceutical context throughout the whole course.

The Pharmaceutical GMP Auditor/Lead Auditor Course covers the requirements of European Union GMP (EU GMP), including the requirements of ICH Q9 and 10, and how these are used as the main reference base when auditing pharmaceutical manufacturing sites. Also included in the course is an overview of key standard for suppliers to the pharmaceutical industry, including ISO 9001, Active Pharmaceutical Ingredient GMP (API GMP), Excipient GMP, Packaging Supplier Standards as well as Good Distribution Practice (GDP) and how these should be used when auditing suppliers.

The Pharmaceutical GMP Auditor/Lead Auditor course explains the role of the auditor to professionally audit a modern Pharmaceutical Quality Management System (PQMS) and on successful completion of the course can be used as part of registration with IRCA (see later) to become an internationally accredited pharmaceutical auditor.

The Pharmaceutical GMP Auditor/Lead Auditor Course covers the principles of auditing Pharmaceutical Quality Management Systems (PQMS) as detailed in GMP and also the FDA’s “Guidance for Quality Systems” and ICH Q10 “Guidance on Pharmaceutical Quality Systems” as well as the requirements of EU GMP itself.  During the course there are many exercises and workshops to put the lessons learnt into practice.  There is also a final examination at the end of the course.

Quality Management Systems:

  • The latest FDA and EU GMP thoughts on Quality Management Systems.
  • The requirements of GMP, ISO 9000 and their inter-relationship
  • The structure and legal status of EU and USA GMP
  • GMP and Quality Management
  • The requirements of GMP and the importance of product quality and the patient
  • Performing audits to GMP
  • Auditing the Warehouse, Production, Packaging and Laboratories
  • Auditing systems – Training, Internal Audits, Management Review, Deviations, Complaints, CAPAs
  • The importance of getting to the root-cause of the problem

Auditing Suppliers:

  • Supplier standards (API GMP, Excipient GMP and Packaging Suppliers Standards)
  • The Falsified Medicines Directive and Good Distribution Practice
  • The evolving role of Quality Assurance – thinking about more than product quality
  • The enhanced role for Senior Management within a Pharmaceutical Quality Management System
  • ICH Q8, 9 and 10 and their role in a modern forward thinking pharmaceutical company
  • Using audits to promote continual improvement
  • Thinking beyond GMP and product quality – business quality and performance
  • Organisational efficiency, effectiveness and continual improvement

Auditing:

  • Reasons for first, second and third party audits – using them effectively
  • How to plan, execute, report and close-out internal and external audits
  • Opening and closing meetings
  • Auditing Senior Management and their commitment to the system
  • How to perform audits professionally
  • Audit role-play exercise – with pharmaceutical facility video and over 300 documents and records to review
  • Auditing functions, departments and processes
  • Good auditing techniques
  • Checklist construction
  • Auditing for compliance to GMP
  • Getting to the root-cause of a problem
  • Adding value as an auditor
  • How to conduct audits that promote increased process performance
  • ISO 19011 guidelines for quality and management systems auditing

Live Online Interactive Training

This course is currently only available using our proven ‘live online interactive’ format. Select the tabs below to find out more:

Stay Safe - Attend from home or whilst at work

With 2 and sometimes 3 expert facilitators and a maximum of 10 delegates our course will utilise state-of-the art interactive online classroom software that will enable you to:

  • chat online with the facilitators and other delegates
  • raise your ‘virtual’ hand to ask a question
  • participate anonymously in a poll or survey and see an instant display of the class results
  • undertake exercises on your own or in a group

And best of all no travel is needed nor a stay in a hotel reducing any risks of COVID-19 and saving you a lot of time, hassle and money.

 As always we will ensure this event is inspirational, enjoyable and educational. See the feedback from delegates in this article.

What is involved?

For this certified course IRCA lay down strict requirements in terms of the hours of learning (40+), continuous assessment and the supervision of the exam. This means that you will need to undertake just over 3 hours of online learning prior to the 5 day event and that the event itself will be very intensive and includes evening work – see Timetable details above. It is very important that during the 5-day event you focus totally on the course and that distractions are minimal.

We will send you detailed joining instructions once you have booked your place and in sufficient time for you to undertake the pre-course work.. 

Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.

Traditional Classroom Courses

For those of you who would prefer to attend a traditional Classroom course we plan to offer this option in 2022 – see the ‘Course Dates’ panel for availability

Why Inspired Pharma?

Expert Tutors

These tutors have now trained over 1000 delegates on IRCA registered Pharmaceutical Lead Auditor training courses.

Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist.  He initially worked for Evans Medical Limited as a Production Development Scientist.  He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist.  He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations.  He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world.  He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.

sterile products courseAndy Martin started working in the Pharmaceutical industry in 1985 for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager and then latterly as Microbiology Manager for Catalent Pharma Solutions.  In 2012 he became a consultant specialising in Pharmaceutical Microbiology and Quality Systems.

Matt is a dynamic, energetic and authentic trainer who demonstrates his passion and communicates this to all who encounter him. He began his Pharma career at Napp Laboratories before having short spells in related industries. He then spent 15 years with GlaxoSmithKline gaining extensive knowledge of GMP from roles in Packaging, Logistics and QC.

More recently, Matt worked as GMP Learning and Development Manager for Lonza Biologics and draws on all his varied experience to create a lively, relevant training environment.

Ruth has over 35 years’ experience in the pharmaceutical industry beginning in analytical R&D and Quality Control functions before transitioning to Quality Assurance in 2002.  She became a full time Global Quality GMP auditor in 2007 for a biologics company, conducting internal manufacturing and external supplier audits.  Most recently Ruth gained experience in Good Clinical Practice and Good Pharmacovigilance practice Quality systems and has led audit and inspection management activities for all GxPs.  In 2016 she resumed her full-time audit career as a global quality auditor and after 2 years of extensive global travel and GMP/GDP audits, she held the position of Director of Global Quality managing a team of GxP auditors and promoting improvements to the audit quality systems and working practices.

Incredible Delegate Feedback

This course continues to receive superb feedback from attending delegates. We continue to be the main Lead Auditor training course provider to SIX major multinational pharmaceutical companies. As well as delegates finding the course immensely valuable our final examination success rate is currently 95%. The IRCA average success rate for standard Lead Auditor courses is 76.5%. See independently verified reviews about this course below:

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

Quality Assurance or Quality Control?

Quality Assurance or Quality Control? This article outlines the importance of these functions and areas where there may be some overlap.

The Focus of Audits – Have we got it right?

The focus of audits : as a pharmaceutical trainer, auditor and consultant I meet a lot of auditors and look at audit mechanisms a great deal. My impression is that the focus is not always right.

Auditing – Opening and closing meetings – How to do them professionally

No matter what type of audit you are involved in it is essential that it starts and finishes well. Opening and closing meetings offer the forum to do this. A well run and professional opening meeting sets the scene for the audit and, if done well, creates a great first impression. Likewise, a well run closing meeting draws the audit to a close in a professional and controlled manner.

Basic audit findings and EU GMP clauses

This article lists a number of common basic audit findings and the corresponding clause in EU GMP that is relevant. Readers should note that there is often some repetition in GMP, so I have tried to find the best single clause.

Exciting news – the classroom returns

News Update – traditional classes to complement our ‘live online interactive’ format; new January date for Lead Auditor course; new versions of our online courses.

New live online interactive format a great success

All of our training courses are now being delivered using our ‘live online interactive” format. Making the transition away from classroom delivery has been challenging especially for the team delivering our highly successful and intensive 5-day Pharmaceutical GMP Lead Auditor course. But the reviews in this article show how we have risen to that challenge.

Our most popular GMP and QMS articles

This article highlights some of our most popular articles

Guidance for starting a new QMS for a Pharma organisation

This article offers detailed advice for those people working in the Pharma secor who are facing the daunting task of starting a new QMS for the first time.

QMS and Auditing News and Articles

Read our articles on  Auditing and QMS regulatory developments as well as news about our QMS training courses.

About Inspired Pharma

We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.

We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.

Quick Links

Find your way quickly to any part of our website by selecting any of the links in this section:

Our Public Course range

Most of our public courses are currently being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together. In 2022 we will also begin to offer some traditional classroom courses - see details on each course page.

Click on course name for full course details and dates:

Pharmaceutical GMP Auditor/Lead Auditor

Advanced Good Manufacturing Practice

Data Integrity

Documentation and Records in GMP

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module 

QP Quality Management Systems module

Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.

Visit our Independent Reviews.io website