Pharmaceutical GMP Auditor/Lead Auditor Training Course

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

Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor training 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 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.  Why not attend this highly praised and prestigious course, which has been used for training hundreds of pharmaceutical auditors over the past 10 years? Attend our 5-day Pharma QMS Lead Auditor Training course and you will leave with the knowledge, skills and enthusiasm to achieve these goals. The course is available on the following dates:

Course dates Venue Click below to book a place
Monday 26th June to Friday 30th June 2017 ** see below Dublin, Ireland Pharmaceutical Quality Management Systems Auditor/Lead Auditor Training Course
Monday 11th September – Friday 15th September 2017 Reading, Berkshire, UK PQMS Auditor/Lead Auditor Course
Monday 6th November to Friday 10th November 2017 Reading, Berkshire, UK Pharmaceutical Quality Management Systems Auditor/Lead Auditor Course

** This course is now FULL. If you select the ‘Book Now’ button you can add your name to a ‘Waiting List’ in the unlikely case that someone cancels. With the next two events very near to full capacity it might also be best to book on one of these courses now.

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.

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 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.

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.

Who will the course benefit?

Internal and supplier auditors along with key personnel involved in Quality Assurance and Quality Management Systems. The course is also ideal for trainee Qualified Persons (QPs) as well as existing auditors who have had no formal auditor training.  The course is also 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 location:

UK courses (Reading, Berkshire)
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.

IRELAND courses (Dublin)
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.

http://www.nibrt.ie/contactus

JAPAN courses (Osaka)
Earth Environmental Services, Inc., Saito Research Institute Training Center, Saito Life Science Park, 7-11, Saito-Asagi, Ibaraki-shi, Osaka 567-0085, Japan

Please contact us for further details and suggested accommodation.

Course cost:

£2975 (approximately €3500) 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.

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.

To book a course please use the online booking system by selecting the ‘Book Now’ button on the event of your choice (at the top of the screen/page)

Previous 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.

“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 (Consultancy Group)
“Exceeded my expectations”
Pharmacist, SAVE THE CHILDREN
“The best course I have ever attended in my life”
Auditor, STRYKER
“Fantastic tutors – probably the best I have every seen”
QA Auditor, INDEPENDENT CONSULTANT
“Amazing”
QA Auditor, TEVA UK
“Brilliant delivery”
QA Auditor, CRODA
“Fantastic course – with a focus on improving an organisation’s quality culture”
QA Auditor, CRODA
“The tutor styles kept the group motivated”
Quality Manager, JANSSEN CILAG
“Brilliant”
QA Officer, PATHEON
“Fabulous course and fabulous people”
Quality Assurance Specialist, GLAXOSMITHKLINE
“A wonderful course”
Quality Auditor, GLAXOSMITHKLINE
“The best trainers I have ever come across”
QA Team Leader, GLAXOSMITHKLINE
“Very impressed by the amount of passion and belief in the subject”
QA Manager, ASTRAZENECA
“A very enjoyable experience”
Quality Section Head, ASTRAZENECA
“Anyone wanting to audit should attend this course”
QA Auditor, NOVARTIS
“The most value-adding course I have ever been on”
QA Auditor, NOVARTIS
“I learnt so much”
Quality Systems Manager, TEVA
“Very dynamic – fantastic”
QA Specialist, TEVA
“You guys are top notch – well worth the journey (from the USA)”
CAPA Manager, MYLAN
“We have taken so much away from this course that we will use in future audits”
Audit Manager, STRYKER
“The best course I have ever attended in my life”
Auditor, STRYKER
“Brilliant delivery”
QA Auditor, CRODA
“Fantastic course – with a focus on improving an organisation’s quality culture”
QA Auditor, CRODA
“The tutor styles kept the group motivated”
Quality Manager, JANSSEN CILAG
“Brilliant”
QA Officer, PATHEON
“Fantastic – helped me understand the true meaning of ICH Q10”
QA Manager, BENCHMARK VACCINES
“I had heard many great things about this course and it met my expectations”
QA Officer, PHARMASERVE
“A tremendous learning experience”
Director, PHARMACEUTICAL CONSULTING GROUP
“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

Dates:

See top of this page for current public dates. Also available for in-house delivery, if required.

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.

Tutors:

peter

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”.

dom

Dominic Parry
Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.Over the past 15 years he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.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. He is Managing Director of Inspired Pharma Training Ltd.

The tutors have now trained over 800 delegates on IRCA registered Pharmaceutical Lead Auditor training courses.

Course accreditation:

This 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.

To book a course please use the online booking system by selecting the ‘Book Now’ button on the event of your choice (at the top of the screen/page)

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.