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RPi Training

Following a recent announcement by the MHRA this article highlights the importance of the RPi role after the transition period has finished and the RPi training available from Inspired Pharma

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 

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.

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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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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Pharma compliance training

Pharma compliance training

Use Inspired Pharma to deliver your next Pharma compliance training programme deploying either our effective online learning courses, our GMP experts or use both for maximum impact

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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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Dealing with non-conformities

Dealing with non-conformities

When non-conformities are raised during audits a sequence of events needs to follow afterwards in order to deal with the non-conformity correctly.  This post highlights the main process that good auditors should use, as well as highlighting any potential problem areas.

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Errors in procedures

Errors in procedures

The pharmaceutical industry is full of procedures.  This is why GMP is often jokingly re-named to Great Mountains of Paperwork.  Whilst the importance of having good quality procedures in place is vital I often see a focus on getting small problems with procedures...

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Raising non-conformities

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 and whilst it may be the way audits have...

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Documents required by ISO 9001

Documents required by ISO 9001

The ISO 9001 standard is the international standard for Quality Management Systems.  During its review in the late 1990 they removed its "obsession" of needing a documented procedure to cover most tasks.  This is because organisations vary in size and complexity, and...

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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

All of our public courses are 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.

Click on course name for full details:

2020

September 

29 Advanced GMP

October

06 Responsible Person

06 Data Integrity 

09 Good Distribution Practice

12 Pharma GMP Lead Auditor

20 Good Manufacturing Practice

21 Sterile Products

November

10 Internal Auditor

16 Pharma GMP Lead Auditor

24 Problem Solving

30 Pharma GMP Lead Auditor

December

08 Responsible Person

15-17 Multi-day GMP

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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