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QP News

The beginning of the end for the UK QP?

How is your Annex 16 implementation going? Let us know by taking our survey: https://is.gd/zs9y64 What does new Annex 16 require of Pharmaceutical companies and Qualified Persons? Is the risk of being a QP in the UK now more than most people want to contemplate? The results

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Is Germany moving toward a UK style QP study guide?

Is Germany moving toward a UK style QP study guide?

In the UK there is evidence of a shortage of Qualified Persons with pharmaceutical companies finding it difficult to find suitable candidates to fill vacancies.  With many of the original raft of Transitional QPs retiring and only approx. 30 new QPs joining the registers through the UK

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UPDATE Transitional IMP QP – Important News

UPDATE Transitional IMP QP – Important News

Updated Guest post by Kastur Patel – Transitional IMP QP Many of you reading this will be aware that the new Clinical Trial Regulation No 536/2014 does not allow for transitional QPs. There are 2 types of transitional QPs, those who were ‘grandfathered’ in the 1970’s and

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7 Common Myths about QP Training Debunked : A Guide for Senior Managers

White Paper Now Available   Click HERE to download your copy   The Seven Myths: As a practicing Qualified Person, QP trainer and self professed expert on the subject, I am asked the same questions over and over again; “exactly what is a QP?”, “what do I need

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Annex 16 Qualified Person Networking Event 17th July 2014

Annex 16 Qualified Person Networking Event 17th July 2014

Did you miss the Qualified Person Networking event on the 10th of April? Here is another chance to learn about a this hot topic. My sources tell me that the text of draft Annex 16 has now been agreed and we should see publication around the end of

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Dead Babies!

Dead Babies!

This week the news has been dominated by the problems associated with contaminated intravenous Total Parenteral Nutrition (TPN). This product was made by a Specials manufacturer and distributed to a number of hospitals throughout the UK. The product was given to babies in neonatal intensive care units,

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Qualified Person Networking Event – 10th April 2014

Qualified Person Networking Event – 10th April 2014

Are you a Qualified Person, forever going to events where you sit down all day listening to people drone on, and on? Suffering from ‘Death by PowerPoint’?  Want to try something different? Come to the QPQuandary / Lifestar Qualified Person Networking Event Here you will be able

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Role of the Qualified Person

You all know what a Qualified Person (QP) is and does, right? I don’t need to spell it out, here, on a web site aimed at QPs, do I? Um, well, I always had that intention.  You see, one of things that really irritates me in this

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Big Changes Ahead for EU Medical Device Legislation

Big Changes Ahead for EU Medical Device Legislation

“Well what has that to do with me?” you say “I’m a medicinal product QP, Devices don’t need a QP and I don’t need to do any checks on them under the rules and guidelines relevant to my area of responsibility,” OK, so the medicinal product QP

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QP Study Guide Info-Graphic

QP Study Guide Info-Graphic

How does the UK QP Study Guide relate to what the Trainee needs to know? Why is there more emphasis on the Foundation Knowledge Elements, and how do these fit in with the education and experience requirements of the EU directives (2001/83/EC and 2001/20/EC)? What does it

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Latest QP Question

What are the requirements for unlicensed medicinal products in the UK, do you need QP certification? Where would you find guidance?

Latest QP Scenario Practice

Iron Oxide - used as an excipient in many of your products. You find that the supplier has been irradiating the material without your knowledge. What implication does this have for your product? What does this mean for the effectiveness of your supplier oversight and PQS?

Testimonials

"The knowledge, guidance and advice provided by Alex was excellent. Alex has first hand knowledge of the requirements needed for candidates to be successful QPs and provides a level of training to meet these requirements. I can highly recommend QPQuandry as a service provider"
Alex Hern, Sanofi.

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Contact Information

20 Playfield Close, Biggleswade, Bedfordshire, SG18 8JL
Phone: 07813 677741
Website: http://www.qpquandary.co.uk
Email: alex@qpquandary.com"