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.
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. 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 approaching 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.
Make a Booking
The course is available on the following dates and will be 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:
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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 required we can customise the course and/or run over several sessions. If you are interested please contact us at [email protected] .
Select the tabs below to find out all the details you need to know to make a booking:
£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%.
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.
Due to the uncertainties involved in travel at the moment we will be delivering all of our public courses using our proven ‘live online interactive’ technology. Delegate feedback from the courses we delivered in June and July has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times
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.
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).
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.
This course is also based on current Pharmaceutical Quality Group requirements for training pharmaceutical Auditors/ Lead Auditor to audit against a range of pharmaceutical supplier standards.
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.
This is an intensive course with assessments throughout. The timings are as follows:
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
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
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
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.
Click on the tabs below for more details on the content of the course:
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
- 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
- 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 8 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.
Why Inspired Pharma?
These tutors have now trained approaching 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.
Andy 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.
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
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.
Find your way quickly to any part of our website by selecting any of the links in this section:
Our Public Course range
All 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.
Click on course name for full course details and dates:
Online courses available anytime anywhere
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.