QPQuandary
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Posts Tagged QP Duties

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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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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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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EMA Guideline on Process Validation – Consultation

  The EMA (CHMP/CVMP) have issued a consultation on an update to their Process Validation Guideline. The consultation is open until 31st October 2012 and can be found here. http://hometeambbq.com/docs/info/ This update incorporates the requirements and philosphies embedded in the ICH guidelines of Q8, Q9 and Q10, moving away

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GMP Deficiencies – MHRA update to top 10

If you were wondering what to add to your internal audit / inspection schedule for the second half of 2012 the MHRA have been very helpful in providing their top ten list of findings from April 2011 to March 2012.  If you look at nothing else this

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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"