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Does your organisational culture “get” data integrity and it’s importance?

 The MHRA’s GXP data integrity guide was published in March 2018. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority...

The 2018 MHRA GDP Symposium

For those of you who did not attend the 2018 MHRA GDP Symposium or missed their recent blog the key highlights are in this article

Online GMP and GDP courses approved by the Royal Society of Chemistry

We are very pleased to announce that the Royal Society of Chemistry has just approved our suite of online Pharma compliance/refresher training courses

NEW: Responsible Person course scheduled for 2019

News about our new 3-day Responsible Person course will confidently set budding RP’s on a path to becoming qualified in a much shorter timeframe than other 2-day courses 

Ensure your team understand the importance of Data Integrity

Now Available - online Data Integrity training for your team Our 20-minute online Data Integrity training course will ensure your entire team understand the importance of Data Integrity and their...

GDP & RP News and Articles

Read our articles on GDP and Responsible Person (RP) regulatory developments as well as news about our courses in this area. The 5 most recent articles are shown in the slider and the rest are shown below.

Must, Shall and Should – the use of these words in GMP

Must, Shall and Should – the use of these words in GMP

What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.

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Data Integrity – why all the fuss?

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.

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Launch of short on-line GDP course

Launch of short on-line GDP course

This one-hour course is designed to provide people new to the pharmaceutical industry with an appreciation of the main requirements of Good Distribution Practice and/or for refresher/compliance training.

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New course on Data Integrity

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.

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The main differences between GDP and GMP

The main differences between GDP and GMP

The European Union’s guidelines on Good Distribution Practice (GDP) were updated at the end of 2013. This post covers an overview of the main differences between GDP and Good Manufacturing Practice (GMP).

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GDP and GMP training courses

GDP and GMP training courses

Interactive and thought provoking classroom and online GDP and GMP training courses facilitated and developed by Pharma experts with great training abilities

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Curriculum Vitaes in Training Records

Curriculum Vitaes in Training Records

I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records.  This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.

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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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