On Thursday, March 5th, 2015, the Pharma & Care division of PostNL will organize a GDP Masterclass at the University of Antwerp.

One of the speakers at this workshop will be Nick Pople, an internationally renowned GDP expert and Senior Consultant in GDP with Pauwels Consulting.

Back in the eighties, Nick developed some of the original GDP guidelines that become regulation. Since then, he has helped dozens of organizations across Europe with GDP audits, the preparation of GDP audits and operating procedures.

We had a short interview with Nick regarding the contents of his presentation at the PostNL GDP Masterclass on March 5th.

Nick Pople (Pauwels Consulting) to present at PostNL GDP Masterclass on March 5

Nick, can you tell us a little bit about yourself and your GDP experience?

Nick: Sure. I am Nick Pople, I am from the UK and I have been working in and around the pharmaceutical industry for the past 35 years now.

Back in the eighties I was heavily involved in the initial construction of the first GDP regulations for temperature-controlled supply chains.

Together with a senior inspector of the Medicines and Healthcare Products Regulatory Agency (MHRA) I drafted the first set of recommendations for cold chain transportation. These recommendations later became the first EU GDP regulations.

We have continued refining the GDP regulations over the years, but the regulations are still largely the same as the ones we crafted back in the eighties.

That’s interesting Nick. Why did you come up with the initial GDP recommendations in the first place?

Nick: I used to run the childhood vaccination distribution for the Department of Health in the UK. We processed 16,500 orders per day. I was concerned that patients should receive their vaccines in the best possible condition. It was my job to control the temperature throughout the whole supply chain.

So we came up with recommendations for every part of the supply chain except for the production of the vaccines. I was responsible for the quality of the products from the moment they left the pharmaceutical factory until they arrived at hospitals, pharmacies, schools, district nurses or individual patients across the UK.

When did you decide to start helping companies across Europe?

Nick: For many years I’ve helped companies and organizations throughout the UK with setting up and controlling temperature controlled supply chains, with the preparation of GDP audits, the improvement of quality systems and with conducting GDP audits.

In May 2014 I started doing GDP audits across Europe for two reasons: 1) the GDP regulations have changed and 2) extended to include medical devices, veterinary products, cosmetics and dentistry products.

I am currently preparing companies across Europe for GDP audits and I also conduct GDP audits myself. I have been working as an independent consultant since April 2012 and I have been working with Pauwels Consulting on large GDP projects with major pharmaceutical companies in Belgium.

What exactly do your projects with Pauwels Consulting entail?

Nick: In the past few months, I’ve mainly helped life sciences companies with GDP compliance projects for transportation. I’ve helped them with global thermal mapping, supplier audits, supplier validations and quality agreements.

What can we expect form your presentation at the PostNL GDP Masterclass?

Nick: I will give the audience independent insight in GDP audits. Based on my experience with GDP audits I will tell the audience what to do before, during and after GDP audits to become and stay compliant with the GDP regulations.

I will give tips and advice so that companies:

  • have all the necessary information during the GDP audit
  • have all the right people attending the GDP audit
  • have the right support in their own company
  • know how to conduct themselves during a GDP audit to get the most out of it
  • know how they should handle the auditor(s) during the GDP audit
  • know what to do and not to do before, during and after the audit
  • know how to translate the summary of the audit into clear actions
  • know how to deal with the feedback of a GDP audit

And evidently I will illustrate all this with some good and bad practices regarding GDP compliance from the industry without naming specific people or organizations.

That’s great Nick. Can’t wait to see that presentation.

 

More information about GDP?

Do you have questions regarding the current GDP regulations? Do you need help preparing for a GDP audit or do you need certified GDP auditors? Please don’t hesitate and contact us at contact@pauwelsconsulting.com.

And please keep a close eye on our website. We will upload Nick Pople’s presentation on GDP regulations soon after his presentation at PostNL’s Masterclass GDP on March 5th.

If you subscribe to our free newsletter below you will receive a notification as soon as the presentation is published on our website.

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