For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 [email protected]

Pharma supplier selection, approval and management

In this article we explore the controls needed to both approve Pharma suppliers and to control the purchasing of materials from them

Successful Japan Lead Auditor course

We successfully delivered our highly praised GMP Auditor/ lead Auditor training course in Osaka, Japan, for the third time a few weeks ago. The course will be presented again in Osaka next year in early March 2020

Design Criteria for an Effective QMS

Most of you will already have a QMS that has already been designed so  the contents of this video will help you to consider how you can evolve an existing QMS to cope with new regulatory...

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.

GMP Auditing Articles and News

Read our articles on GMP auditing relating to regulatory compliance in the Pharma industry . The 5 most recent articles are shown in the slider and the rest are shown in date order below.

Good auditing techniques

Good auditing techniques

When people talk about good auditing technique it is easy to immediately start covering how to ask questions, how to deal with people and how to make notes.  Whilst this is all true, it is easy to forget that there are 4 stages to the audit process and good auditing technique can be used at all of these stages – as we will see.  This makes for a better audit.

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Non-conformity – not following a procedure

Non-conformity – not following a procedure

A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy.  This is a non-conformity, and should be raised as such.  The problem is – what clause of the standard actually states that you should follow your procedures?  On investigation this is not as easy to find as you might like to think!

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Procedure or documented procedure?

Procedure or documented procedure?

In many standards that exist there are often statements such as “there must be a procedure to control training records”.  Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself.  It surrounds the use of the word “procedure” and what is meant by a procedure. 

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Management Review – what is it for?

Management Review – what is it for?

In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place.

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The benefits of being IRCA registered

The benefits of being IRCA registered

Our 5-day Pharmaceutical Lead Auditor course is registered with IRCA, the International Register of Certificated Auditors.  This is the world's premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses. ...

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Basic audit findings and clauses

Basic audit findings and clauses

When you are auditing you will often find non-conformities. These occur when the department, process or organisation that you are auditing is not following a requirement of the standard that you are auditing against. For many of you who perform audits in the...

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Audit preparation

Audit preparation

I perform a number of audits throughout the year. Most are supplier audits but some are internal audits. In order to make the audits as efficient as possible I recommend good planning for the audit – rather than just turning up on the day and “going with the flow”.

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The Focus of Audits – Have we got it right?

The Focus of Audits – Have we got it right?

Most people will have some involvement with being audited.  In general audits are classified into one of three different types; namely first party, second party and third party.  First party audits are often called internal audits or self-inspections.  Here you are...

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Auditing – Opening and closing meetings – How to do them professionally

Auditing – Opening and closing meetings – How to do them professionally

No matter what type of audit you are involved in it is essential that it starts and finishes well. Opening and closing meetings offer the forum to do this. A well run and professional opening meeting sets the scene for the audit and, if done well, creates a great first impression. Likewise, a well run closing meeting draws the audit to a close in a professional and controlled manner.

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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.

Other Topics

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Forthcoming Public Courses

December

Pharma GMP Lead Auditor 

2020

January

20 Pharma GMP Lead Auditor

28 Responsible Person

February

Data Integrity

11 Good Manufacturing Practice

25 Documentation & Records

March

2 Pharma GMP Lead Auditor Japan

16 Pharma GMP Lead Auditor

24 Advanced Good Manufacturing Practice

31 Good Distibution Practice

31 Sterile Products

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

For more 2020 dates select the green 'See all Courses and Dates' button.

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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