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GDP Auditor

This 2-day course is designed for GDP auditors. It includes how to plan, perform, report and follow up Good Distribution Practice (GDP) audits professionally.
Key informationWhy inspired

Designed for auditors who perform GDP audits

Do you perform, or are you about to start performing, GDP audits?  If so, then this course is just for you.  On our 2-day GDP Auditor course we cover how to professionally plan, perform, report and follow-up audits against GDP (Good Distribution Practice).  This course is aimed at new auditors, who have had no formal auditor training, and will show them how to be an effective and efficient GDP auditor.

See and download our Auditing Brochure detailing our courses and services in this important area.

Key features of our 2-day GDP Auditor course: 

Lively and highly interactive course

Our 2-day format is designed to ensure that  this is a lively and highly interactive course with practical workshops and exercises throughout the programme. See the incredible feedback from delegates about our ‘live online interactive ‘ courses  in this article.

Maximum class sizes

For maximum interactivity and effectiveness, our class size is limited to  either 10 delegates  (live online interactive)  or 12 delegates (classroom) with at least two tutors. The quality and effectiveness of our courses is unrivalled in the industry.

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

This GDP Auditor course is available for in-house presentation, either on-site or virtually.  Please contact us for further details.

Booking details

Select the tabs below to find out all the details you need to know to make a booking on our GDP Auditor training course:

Course cost

£1390  per delegate plus VAT. Course will be charged in GB pounds.

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.

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.

If you are attending a classroom course then, in addition,  a lunch and tea/coffee will also be provided each day.

 

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 RP 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.

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 3 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 GDP Auditor training course:

Who will the course benefit?

This course is aimed at people who are about to start to perform GDP audits.  It is ideal training for new GDP auditors, as well as auditors who have had no formal auditor training.  The course is specifically designed for Responsible Persons (RP) who need to audit within their own organisation, or perform audits of contract warehouse and transportation organisations.

Course Times:

The GDP Auditor course runs between 09.00 – 16.30 (UK time) each day.  This includes lunch and break times.

 

Course Details

Click on the tabs below for more details on the content of this GDP Auditor training course:

Course Overview

This GDP Auditor training course is designed for those new to auditing.  The course covers how to plan, perform, report and follow-up GDP audits professionally.  Delegates will learn about GDP and how to audit against European Union Good Distribution Practice (EU GDP).  EU GDP is used as the main auditing standard throughout the whole course.  The course is presented in a pharmaceutical wholesale and distribution setting.  Delegate will leave the course will all of the tools that they need to perform GDP audits professionally.

Course Content: Day 1

  • Quality Management Systems and their evolution
  • European Union GDP – its structure and legal status
  • Types of audits and reasons for performing them
  • The GDP requirements for internal and supplier audits
  • Focus areas when performing GDP audits
  • Auditing a warehouse and what to look for
  • Auditing a transport organisation and what to look for
  • Effective audit planning and preparation

Course Content: Day 2

  • Review of documentation before the audit
  • Good auditing techniques
  • Checklist construction
  • The opening meeting
  • Audit role-play exercise
  • The closing meeting
  • Finding faults and identifying opportunities for improvement
  • Non-conformity reporting and corrective actions
  • Audit reports and post-audit activities

Why choose Inspired Pharma?

Expert Tutors

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.

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.

Delegate Feedback

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

The benefits of being IRCA registered

Our 5-day Pharmaceutical GMP Auditor/Lead Auditor Course is registered with IRCA, the International Register of Certificated Auditors (IRCA Ref:PR325).  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses.

Raising non-conformities

Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing.This article the best way of dealing with non-compliances using modern standards.

Documents required by USA GMP (21 CFR 211)

The article covers the requirement of written procedures required by 21 CFR 211

Documents required by EU GMP

The list below details the documented procedures specified as being required by EU GMP. It is worth pointing out that many times in GMP there is a requirement to have a “procedure”, but this is not the same as a “documented procedure”.

GMP Calibration

Around a pharmaceutical manufacturing site there will be many measuring devices that require calibration. GMP requires the calibration of such devices with similar requirements in both EU and USA GMP

Dealing with problems – for good

Problems happen in work and in life.  Problems also happen within any quality system. GMP requires problems to be dealt with correctly.

CAPA – time for a rethink?

Most manufacturing sites these days have CAPA systems – a mechanism to capture, record, control and approve or reject Corrective Actions. However despite this approach many organisations feel that they are still in “fire-fighting” mode – always dealing with yesterday’s problems rather than preventing future issues from occurring.

ISO 9001 versus GMP – Part 2

One of the main problems of comparing GMP and ISO is that the two standards are not the same and are not really trying to do the same thing. This article highlights the key differences.

QMS News and Articles

Read our articles on  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

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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 began to once again offer 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

Good Distribution Practice

Good Manufacturing Practice

Internal Auditor

GMP Problem Solving

Responsible Person (RP)

Sterile Products

Webinar: Microbiological control in pharmaceutical production 

QP Courses - full range

See and download our Auditing Brochure detailing our courses and services in this important area.

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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