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Digitalizing healthcare step by step

21/8/2017 - Filip Heitbrink, CEO at QbD Software

In a world that is becoming more digital each day, the healthcare environment is facing complex challenges. It’s clear that healthcare companies will need to…

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Preparing for growing challenges in pharmaceutical serialization

1/8/2017 - Vic Ampen, Serialization Expert and Pharmaceutical Product Engineer at Quality by Design

Serialization is rapidly emerging in the pharmaceutical world. To fight counterfeit drugs, more and more governments demand that every single sales product gets a unique…

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Echoes from a QbD training: the power of Lean

14/7/2017 - Katrien Janssens, Senior Consultant at QbD/ Training Manager

Specialised trainings are one way in which we keep investing in the expertise of our QbD team. Three QbD colleagues share their views on the…

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Ready for the new FDA and EU rules for medical devices?

13/7/2017 - Yves Dène, Lead Consultant CSV at Quality by Design

The rapid digital transformation drives a steady flow of new recommendations and rules. The industry must adapt and comply. What is the impact of the…

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Antleron & QbD team up to create a landslide in healthcare

11/5/2017 - Martijn Reniers, Managing Partner at Quality by Design

A whole new era in healthcare is coming closer every day. Thanks to the crossover of 3D printing and biology, medical solutions will be personalised…

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Data integrity in the pharma industry – a short introduction

14/12/2016 - Yves Dène, Lead Consultant CSV at Quality by Design

Over the last couple of years, the data integrity topic has received more and more attention. Recently, the American Food and Drug Administration (FDA) issued…

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Pharmacy and automation in Japan and Belgium – the differences

25/11/2016 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

As a pharmaceutical project engineer at QbD, every day is different.

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The bright future of the Belgian life sciences industry

4/10/2016 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

In the last three years, the life sciences industry has realized around 3,000 to 3,500 extra jobs in Belgium. This comes down to over 1,000…

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New breakthrough in negotiations around orphan drugs

23/6/2016 - Kristien Reekmans, Pharmaceutical Project Engineer

The latest developments in the market for orphan drugs are promising. In addition to the Netherlands and Luxembourg, the Flemish minister of public health Maggie…

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From CCKL to ISO 15189 – what you should know

18/4/2016 - Sven Mus, Managing partner, Project delivery & technical sales at Neomatics

Clinical and pathological laboratories in the Netherlands are undergoing major changes. A growing number of them are applying for Dutch ‘Raad voor Accreditatie’ (RvA) accreditation…

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Pharmaceutical production errors – why fines are not the answer

24/2/2016 - Martijn Reniers, Managing Partner at Quality by Design

45,000 euros. It’s the fine pharmaceutical companies have to pay when they are unexpectedly unable to deliver certain medicines. The Dutch minister of Public Health,…

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Factory Acceptance Testing: not a simple business

19/1/2016 - Kin Chun Cheung, Project Manager Pharmaceutical Engineering at Quality by Design

Early November 2015, I set off for a ten day trip to Scandinavia. Main purpose of the trip? Checking on a completed filling and packaging…

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HistoGeneX chooses Quality by Design for quality assurance

15/12/2015 - Yves Dène, Lead Consultant CSV at Quality by Design

QbD supports HistoGeneX’ strong growth by optimizing computer systems HistoGeneX summons the assistance of Quality by Design, the expert in quality assurance for enterprises in…

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Eudralex Vol 4: New annex 15: Qualification (PART 2)

5/12/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

Process validation The process validation section has been doubled from 2 to 4 pages, with extra sections about verification of transportation, validation of packaging, qualification…

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Pharmaceutical industry: compliancy doesn’t always equals quality

1/12/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

When you say pharmacy, you say compliancy. Bringing new pharmaceutical products onto the market is subject to very strict rules regarding the development, manufacturing and…

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QbD in the United States: work hard, play hard

20/10/2015 - Elly De Bruyn, HR Manager at Quality by Design

‘Opposites’: that’s the word that comes to mind when looking back on my four week adventure for QbD in the United States. Extreme opposites. In…

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Medical device legislation: how to keep up to date

13/10/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

On September 26th, 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council, to revise existing legislation…

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EudraLex Vol 4: New Annex 15: Qualification

13/10/2015 - Bart Van Acker, Founder/Managing Director at Quality by Design

From 1 October 2015, the revision to Annex 15 of EudraLex Vol 4 comes into operation, qualification and validation. Annex 15 has been in effect…

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