+44 1635 866699 [email protected]

Pharmaceutical GMP Auditor/Lead Auditor Training Course

Europe's leading and most successful IRCA registered Pharmaceutical GMP Auditor/Lead Auditor training course.

 

Key Course InformationWhy Choose Inspired?

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 auditorOur 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.

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Make a Booking

The course is available on the following dates:

Monday 10th September to Friday 14th September 2018

Venue: Reading, Berkshire UK

Monday 5th November to Friday 9th November 2018

Venue: Manchester near Airport, UK

Monday 3rd December to Friday 7th December 2018

Venue: Reading, Berkshire UK

Monday 21st January to Friday 25th January 2019

Venue: Reading, Berkshire UK

Monday 4th March to Saturday 9th March 2019

Venue: Osaka, Japan – for more details please email  us or use the link below to get our contact details

Monday 18th March to Friday 22nd March 2019

Venue: Reading, Berkshire UK

Monday 13th May to Friday 17th May 2019

Venue: Reading, Berkshire UK

Monday 24th June to Friday 28th June 2019

Venue: Dublin, Eire

Monday 23rd September to Friday 27th September 2019

Venue: Reading, Berkshire UK

Monday 4th November to Friday 8th November 2019

Venue: Manchester near Airport, UK

Monday 2nd December to Friday 6th December 2019

Venue: Manchester near Airport, UK

All Dates:

The cost is £2975 (approximately €3300) plus VAT. Course will be charged in GB pounds. Please note that events taking place in 2019 cost £3295 plus VAT. The cost of accommodation is not included in the course cost. For full details of what is included in the cost see below. To find out more about each venue select the link in blue in this sentence.

VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, however 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.

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 course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

Group Bookings offer

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.

Key Course Information

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 12 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.

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.

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.

Name change – please note that the official name of this course has been changed by IRCA. This course used to be called a “Pharmaceutical Quality Management Systems (PQMS) Auditor/ Lead Auditor training 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.

Course cost:

£2975 (approximately €3300) plus VAT. Course will be charged in GB pounds.

VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, however 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.

The cost of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel. It is recommended that delegates stay at or close to the course venue.

The cost includes:

  • Refreshments and lunch during the course times.
  • 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%. 
Course Times:

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

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 about an hour’s evening work each night.

Course contents

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

If you would like to find out more, please contact us for more information.

Course venues

The cost of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel. It is recommended that delegates stay at or close to the course venue as this is an intensive course with assessments throughout. The timings are as follows: 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 about an hour’s evening work each night.

Reading, Berkshire, UK

The Holiday Inn - Reading South, 500 Basingstoke Road, Reading, Berkshire, RG2 0SL, UK. The hotel is very close to Junction 11 of the M4 - 25 miles west of London's Heathrow Airport.

Telephone: + 44 (0) 871 942 9067

e-mail: [email protected]

Web:

http://www.hireadingsouthhotel.co.uk/

A special rate of £121 (including VAT) has been agreed with the hotel (subject to availability). This is for Bed and Breakfast and includes internet access. Quote "Inspired Pharma" when making your booking.

Click on map below for a larger scale version:

Manchester, UK near Airport

Crowne Plaza Manchester Airport,  Ringway Road, Manchester, M90 3NS

The hotel is very close to Manchester Airport with frequent shuttle buses to and from hotel.

Click on map for a larger scale version of map shown below: 

 

Telephone: +44 (0) 161 498 4000

e-mail: [email protected]

Web:

https://www.ihg.com/crowneplaza/hotels/gb/en/manchester/mchwt/hoteldetail

A special rate of £117 (including VAT) per night for the 4-night stay has been agreed with the hotel (subject to availability). This is for Bed and Breakfast and includes internet access and parking. Use the email address above and quote “Inspired Pharma” when making your booking to obtain these rates.

IRELAND courses (Dublin)

These are held at The National Institute for Bioprocessing Research and Training (NIBRT), Fosters Avenue, Mount Merrion, Blackrock, County Dublin, Ireland

Telephone: +353 (0) 1 215 8100

e-mail: [email protected]

For directions and hotel details please visit NIBRT’s own website (details below).

The Radisson Blu hotel is within walking distance of the course venue.

https://www.nibrt.ie/contactus

JAPAN (Osaka)

We have now run two very successful courses in Japan and have plans to do so again in 2019. The date and details are shown above.

If you would like to find out more, please contact us for more information.

Middle East

We are planning to run a course in the Middle East, probably Dubai, within the next year.

If you would like to find out more, please contact us for more information.

Why Inspired Pharma?

Expert Tutors

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

Peter Lavis

Arguably the finest Quality Management Systems tutor in the business, Peter’s enthusiasm for quality system thinking and his outstanding training abilities have gained him international praise and appeal. Peter is a leading quality management systems auditor and encourages auditors to think outside the “GMP box”.

Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents.

sterile products course

Andy Martin

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 laterly as Microbiology Manager for Catalent Pharma Solutions.  In 2012 he became a consultant specialising in Pharmaceutical Microbiology and Quality Systems.

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%. 

Very impressed by the amount of passion and belief in the subject

QA Manager, ASTRAZENECA

The most value-adding course I have ever been on

QA Auditor, NOVARTIS

I had heard many great things about this course and it met my expectations

QA Officer, PHARMASERVE

Exceeded my expectations

Quality Systems Coordinator, GLAXOSMITHKLINE

I cannot speak highly enough of this course

Quality Specialist, ASPEN

Fantastic – this was seriously one of the best (perhaps the best) training courses I have ever been on

QA Manager, CLINICAL BIOMANUFACTURING FACILITY (OXFORD)

One of the best training experiences I have had

CEO, NDA

The best course I have ever attended in my life

Auditor, STRYKER

Fabulous course and fabulous people

Quality Assurance Specialist, GLAXOSMITHKLINE

The best trainers I have ever come across

QA Team Leader, GLAXOSMITHKLINE

Fantastic course – with a focus on improving an organisation’s quality culture

QA Auditor, CRODA

The way the tutors took us through the course was fantastic. They picked us up and the enthusiasm and passion made me a big fan of this course

QA Auditor, GLAXOSMITHKLINE

Thank you for the week. I thoroughly enjoyed the course and came away with a lot of information. I will be highly recommending Inspired Pharma.

QA Specialist, AZUR PHARMA

I was worried that the course would be very monotonous and boring, and would involve hours of reading. I am glad to say that the course was anything but that! There are many tutors that could do with a lesson in teaching from you guys. I really do admire the way you make the course interesting and involve the delegates in active learning.

QA Officer, PHARMASERV

A tremendous learning experience

Director, PHARMACEUTICAL CONSULTING GROUP

The best training in Quality I have ever had

Supplier Quality Auditor, GSK BIOLOGICALS

Exceeded my expectations

Pharmacist, SAVE THE CHILDREN

Both Dominic and Peter from Inspired Pharma Training are excellent at delivering a very intensive course and the results that their students get reflect their outstanding ability

Regulatory Affairs, ASPEN PHARMACARE

See recent independently verified reviews about this course from Reviews.io

 

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

What to include in an audit report

An audit report is an essential part of the audit and this article lists the key items that you should ensure are in your audit report contents.

A Quality Manual – what is it and what should it contain?

A Quality Manual is a very useful document that not only gives guidance and direction to an organisation’s own personnel, but gives a potential customer, inspector or auditor an appreciation of an organisation from the outside. If designed well it can be used as a tool to sell an organisation, to show what a positive quality ethos they have and can show how good an organisation is and how seriously it takes its Quality Management System.

Planning to perform audits

As with everything else in life, planning is everything. An audit is much more effective for everyone concerned if the auditor takes a short amount of time to plan the audit correctly. This article incudes a checklistlist of things to include in the planning of any effective audit.

Management Review – who, what, where and when?

The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?

Standards to use when auditing suppliers

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers this post lists of all the key standards to use when auditing suppliers including links to all of the key documents and authorities.

EU GMP Chapter 9: Self-Inspection – time for an update?

In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts

Data Integrity – why all the fuss?

The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.

Problems and deviations – avoid blaming the operator

You should be careful of putting “human error” as the cause of a problem, without considering what caused the human to make the error in the first place

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

Forthcoming Public Courses

October

09 Data Integrity
17 Good Manufacturing Practice

November

05 Pharma GMP Lead Auditor Manchester, UK
13 Internal Auditor
20 Sterile Products
27 Problem Solving

December

03 Pharma GMP Lead Auditor

All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.

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.

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