+44 1635 866699 [email protected]

Pharma Internal Auditor course - plan, perform, report and follow up audits professionally

This 2-day course is specifically designed for auditors who perform internal audits in a pharmaceutical environment.
Key informationWhy inspired

Designed for auditors who perform internal audits in a pharmaceutical environment

Do you perform, or are you about to start performing, internal audits?  If so, then this course is just for you.  On our 2-day Pharma Internal Auditor course we cover how to professionally plan, perform, report and follow-up internal audits against GMP.  This course is aimed at new auditors who have had no formal training and will show them how to perform effective and efficient audits in a pharmaceutical environment.

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Make a Booking

Our 2-day Pharma Internal Auditor training course is available on the following dates:

Tuesday 13th November to Wednesday 14th November 2018

Venue: Reading, Berkshire UK

All Dates:

The cost of the Pharma Internal Auditor course is £1190 plus VAT. Course will be charged in GB pounds. 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 the venue select the link in blue in this sentence.

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

Key Course Information

Who will the course benefit?

Our Pharma Internal Auditor course is aimed at people who perform internal and external audits, people who manage audit programmes as well as individuals who host  auditors of their own organisation.

Course overview

This Pharma Internal Auditor course is designed for those new to auditing.  The course covers how to plan, perform, report and follow-up audits professionally.  Delegates will learn about GMP and how to audit against GMP (as a standard) as well as the newer requirements of Q10 (Quality Management) and the ramifications of this document to GMP, including recent updates to EU GMP Chapters 1 and 2.

Course content

Day 1     Quality Management Systems and auditing

  • Quality Management Systems and their evolution
  • GMP – structure and legal status
  • Types of audits and reasons for performing them
  • GMP requirements for internal and supplier audits
  • GMP and Pharmaceutical Quality Management development
  • ICH Q9 and 10
  • An overview of ISO 9001 and how many of its requirements are incorporated into ICH Q10
  • Effective audit planning and preparation

Day 2     The audit process

  • 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

Course cost:

£1190  per delegate 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.

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.

Times: 

Day 1:  09.00 – 17.00        Day 2:  09.00 – 16.30

Venue details

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.

Map

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Why choose Inspired Pharma?

Expert Tutors

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.

Delegate Feedback

Presented with great energy – I enjoyed this course

QA Officer, CATALENT

Excellent course – I highly recommend to anyone involved in audits

Quality Administrator, DERMAL LABORATORIES

Not an easy subject to make interesting – but you did it!

Compliance Manager, UCB PHAMA

A great course delivered in a brilliant way

Product Development Manager, TEVA

Passionate tutors and a very interactive course

Shift Manager, THORNTON & ROSS

The great enthusiasm from the tutors made the course so interesting

QC Analyst, EISAI

The best training course I have ever been on

Senior QA Officer, THORNTON & ROSS

I liked the passion and commitment of both tutors

Team Leader, CATALENT

Fantastic

QA Specialist, TEVA

Thank you for providing me with more confidence

Senior Quality Specialist, JANSSEN-CILAG

A fantastic double-act

Product Development Manager, TEVA

Fantastic

Head of Drug Safety, JANSSEN-CILAG

Recent independently verified reviews about this course from Review.io

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

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.

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

Key GMP personnel and their duties

Some of the most popular articles on our blog are the four we published some four years ago about the duties of key personnel in GMP. For more recent visitors to the blog I thought it might be helpful to remind everyone about this resource.

New course on Data Integrity

This course has already run very successfully on an in-house basis for our clients who are increasingly concerned to ensure that they comply with the latest regulations from the EU and the FDA regarding the data integrity of their systems.

Update to EU GMP Chapter 8 – Complaints, Quality Defects and Product Recalls

Chapter 8 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.

Update to EU GMP Chapter 5 – Production

Chapter 5 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.

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

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

Forthcoming Public Courses

June

12 Good Manufacturing Practice
19 Sterile Products
25 Pharma GMP Lead Auditor Dublin, Ireland

September

10 Pharma GMP Lead Auditor
19  Documentation and Records

October

09 Data Integrity
10 Good Distribution Practice
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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