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Guidance for starting a new QMS for a Pharma organisation

This article offers detailed advice for those people working in the Pharma secor who are facing the daunting task of starting a new QMS for the first time.

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

The roles of the Heads of Production & QC and the Qualified Person

In this video, we look at “The roles of the Heads of Production & QC and the Qualified Person” and what GMP’s requirements are when it comes to roles and responsibilities as well as the specific duties of these three individuals.

QP News and Articles

Read our articles on regulatory developments of interest to trainee and qualified QP’s as well as news about our pharmaceutical training courses. The 3 most recent QP articles are shown in the slider and the rest are shown in date order below.

The positioning of the Qualified Person (QP) within the organisation

The positioning of the Qualified Person (QP) within the organisation

In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP).  In this post we look at the organisation of these people within the business. 

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Duties of key personnel in GMP – Part 3 (Engineering)

Duties of key personnel in GMP – Part 3 (Engineering)

From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP. In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality. The role of the Engineering Manager is therefore critical.

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Duties of key personnel in GMP – Part 2 (Quality Assurance)

Duties of key personnel in GMP – Part 2 (Quality Assurance)

From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP.  EU GMP does require you to have a QA system, but there is no mention of who should manage the system.  In a number of courses that I have presented in the past...

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Proposed update to EU GMP Chapter 2 “Personnel”

Proposed update to EU GMP Chapter 2 “Personnel”

This article provides an overview of the current proposed changes to EU GMP Chapter 2 on Personnel.  As with similar blog articles before on Chapters 4, 5 and 8 readers are reminded that the proposed update is still in the DRAFT format (Chapter 2 Draft) and is...

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ISO 9001 versus GMP – Part 2

ISO 9001 versus GMP – Part 2

A lot has been said about ISO 9001 in the pharmaceutical industry.  This article tries to compare the two fairly.  You should read Part 1 first to get some idea of the differences.  One of the main problems of comparing GMP and ISO is that the two standards are not...

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ISO 9001 versus GMP – Part 1

ISO 9001 versus GMP – Part 1

A lot has been said about ISO 9001 in the pharmaceutical industry.  With pros and cons and comparisons to GMP made all the time.  This will be discussed more in a later article, but as a starter I have listed the clauses of ISO 9001 below.  Those in purple  text are...

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Proposed update to EU GMP Chapter 5 “Production”

Proposed update to EU GMP Chapter 5 “Production”

What’s new in the latest version? The EU GMP Chapter 5 on Production is currently being reviewed.  A draft update document is currently available.  This article is a commentary on the DRAFT version currently in circulation.  Many of the suggested updates are in-line...

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Proposed update to EU GMP Chapter 4 “Documentation”

Proposed update to EU GMP Chapter 4 “Documentation”

 What’s new in the latest version?  The EU GMP Chapter 4 on Documentation came into force on 30th June 2011.  Many of the updates were in-line with existing good practices.  Some of the main changes are summarised below.  You should refer to the actual...

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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.

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Forthcoming Public Courses

September

23 Pharma GMP Lead Auditor

October

8 Data Integrity

10 Good Manufacturing Practice

15 Responsible Person

22 Advanced GMP

November

Pharma GMP Lead Auditor Manchester, UK

6 Documentation and Records

7 Good Distribution Practice

12 Pharma Internal Auditor

19 Sterile Products

26 Pharma Problem Solving

December

Pharma GMP Lead Auditor 

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

For 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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