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- Eerste werkervaring achter de rug? QbD geeft je ruimte om te groeien.
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- A Complete Guide to Computer System Validation (CSV): What is it and why do we need it?
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Blogs
- Team up with a Contract Research Organization (CRO) dedicated to medical devices to boost your clinical research strategy
- Finding your way through the maze of international, European, and harmonized standards for medical devices
- AI and machine learning validation: strategies and examples
- What is the purpose of Periodic Reviews in CSV?
- The importance of high-quality gas distribution networks for critical process gases, even in the early development phase
- New edition of the GAMP 5 guide ‘A Risk-Based Approach to compliant GxP Computerized Systems’ expected in 2022
- Why self-inspections or internal audits are essential for your QMS
- The regulatory pathway for your custom-made medical device
- Medicine advertising in Belgium: a brief regulatory overview
- Person Responsible for Regulatory Compliance or ‘PRRC’: meaning, requirements, and responsibilities
- 6 common myths about life sciences consultancy
- Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring
- Meet QbD Ambassador and Clinical Pharmacology & Pharmacometrics project lead Thomas Van Looy
- Data migration in CSV: definition, purpose, and best practices
- Meet QbD Ambassador and Device Compliance Specialist Catarina Cruz
- New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?
- Clinical Evaluation Report (CER): a must-have for all medical device classifications
- How to use electronic signatures in regulated industries?
- Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy
- What is decommissioning in CSV?
- 10Y Steven Vinkx at QbD: from Project Engineer to Head of PMO
- Clinical evaluation for medical devices under MDR: a brief guide
- EDQM and the CEP of the future
- CAR-T cell therapy: highlighting the main components, manufacturing process, and prospects
- 10Y Dominiek Rossillion at QbD: from Quality Engineer to Business Development Manager
- What is EUDAMED and what new requirements should medical device companies take into account?
- GAMP categories for computerized systems: what are they and what are they for?
- 10 questions for ‘10Y anniversary girl’ Katrien Janssens
- 3D printing enables patient-specific medical devices for a better quality of care
- The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization
- Quality Control challenges in closed systems: implementing AI as an in-process control
- A Day in the Life of a QbD MD Specialist
- Cell therapy as an ATMP: introduction, definition, and subtypes
- 10 Questions for ‘10Y anniversary boy’ Jeroen Verhoeven
- QbD and TRIUM awarded with Baanbrekende Werkgever ‘22 certificate
- Dendritic cells: effective sentinels for immunotherapies
- Why NK cells are a major breakthrough in the field of ATMPs
- From IVDD to IVDR: avoid these pitfalls to get your CE marking in time
- Medical device combination products: what regulations should you apply before marketing them in the EU?
- IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers
- MDR impact on MDSW: what has changed from MDD?
- Medical Device Industry Trends: on wearables, AI, POC testing, IoT, and more
- QbD Academy welcomes 15 young graduates to jumpstart their careers in life sciences
- Unraveling Artificial Intelligence in Medical Devices: what do we know so far?
- SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?
- 5 consequences of Brexit when selling medical devices in the UK
- ATMPs: translating the expertise into a GMP process
- QbD & TRIUM’s 10Y International Sports Challenge: a mix of fun, exercise, and team spirit!
- Is your product a medical device? Well, that depends…
- Why Medical Device Risk Management is as complex as it is crucial
- How QbD is investing in the new hybrid way of working
- Clinical Trials for ATMPs: which challenges to overcome?
- From idea to post market surveillance: the phases of the medical device lifecycle
- 10 things you should know before validating Computerized Systems
- Smart factories: How digital twins can strongly improve your ATMP manufacturing processes
- Why QP challenges in ATMPs are different & what you need to know!
- How do you reduce the Cost of Goods, which is key to affordable ATMPs?
- What you need to know to make your medical device UDI-ready in time
- The Corona World Games – A throwback by the winning team
- Post-Market Surveillance of Medical Devices
- Medical devices: innovations versus regulations
- Is your ATMP platform robust enough to deal with material input variability?
- Meet our new partner TRIUM Clinical Consulting: interview with Managing Director Christof Debèfve
- CAR T and TCRs for the market: current state and future perspectives
- Quality by design methodology for the pharmaceutical industry
- What to focus on when validating a computer system? (3)
- Automation Pyramid – FAQ
- What to focus on when validating a computer system? (2)
- Three important trends in technology transfers
- ATMP manufacturing for the market: main hurdles to be tackled to ensure a high-quality end product.
- What to focus on when validating a computer system
- The use of wearables in diagnosing and preventing of diseases
- The importance of a dedicated team and skilled project manager for technology transfers
- How to start with computer system validation?
- RA/QA guest lectures – week 5 – FDA & Medical Devices
- Tech transfers: what are the drivers of complexity?
- RA/QA guest lectures – week 4 – Software as a medical device and Qualification & Validation
- RA/QA guest lectures – week 3 – Roadmap to CE-marking
- These factors can make or break your technology transfer
- Development of face masks in the fight against the COVID-19 pandemic
- Innovations in Medical Technology: The Future of Healthcare is Data
- Starting a new job in Corona times: this is how Katrien experienced it at QbD
- A day in the life of… our QbD recruitment team
- A Day in the QbD life of… Frederick Tison – Corona times
- Anything you need to know about ATMPs: FAQ
- RA/QA lectures at the University of Liège – week 2
- Sweating out the Monday blues: via livestream this time!
- From QMS to Validation: QbD teaches future biomedical engineers in Liège
- ATMPs in a nutshell: what you should know about classification, quality and go to market
- Artificial Intelligence in Advanced Therapy Medicinal Products
- Computer Systems: is Assurance the new Validation?
- A day in the QbD life of… Jolien, Pharmaceutical consultant
- How will Brexit affect the pharmaceutical industry in European Union?
- Market release of vaccines: European Union versus the United States of America
- A day in the QbD life of… Julie, HR business partner at QbD HQ
- Watch out for the Pink Army
- A day in the QbD life of… Evelyne, pharmacist and Qualified & Responsible Person
- How Europe is fighting falsified medicine
- A day in the QbD life of… Lieve, downstream process expert at eTheRNA immunotherapies
- Belgium as pioneer in ATMPs: now and in the future
- Technical writing: the importance, do’s and don’ts
- Process Validation as focal point for Competence Center Qualification & Validation
- Market introduction of new medical devices: submit under MDD or MDR?
- A day in the life of … Imrane, Process Engineer
- Sweating out the Monday blues
- A day in the QbD life of… Henrik, QA compliance consultant
- Serialization in the EU can become a competitive advantage if you dare to innovate
- EU GMP Annex I: Are we ready for the challenges posed after its revision?
- MDR regulation and failing implant coordination: Improvements to be made
- La revolución de la impresión 3D en Terapias Avanzadas.
- Our Healthcare & 3D printing: a match made in heaven?
- Pioneering with Artificial Intelligence to make personalized cell therapy more accessible
- A critical look at the new Annex 1 draft of the EU GMP
- Challenges & opportunities in the Medical Devices landscape
- Medical Devices: a broad category for countless vital applications
- Ensuring quality management in other industries? Check!
- Ensuring full data integrity, without any exceptions
- Updating Good Clinical Practice E6(R2)
- MHPRA in UK releases GxP Data Integrity guidelines
- New Annex 1 draft of the EU GMP
- What are Good Distribution Practices?
- New steps by FDA & EU to eliminate double drug inspections
- New steps by FDA & EU to eliminate double drug inspections
- Digitalizing healthcare step by step
- Preparing for growing challenges in pharmaceutical serialization
- Echoes from a QbD training: the power of Lean
- Ready for the new FDA and EU rules for medical devices?
- Antleron & QbD team up to create a landslide in healthcare
- Data integrity in the pharma industry – a short introduction
- Pharmacy and automation in Japan and Belgium – the differences
- The bright future of the Belgian life sciences industry
- New breakthrough in negotiations around orphan drugs
- From CCKL to ISO 15189 – what you should know
- Pharmaceutical production errors – why fines are not the answer
- Factory Acceptance Testing: not a simple business
- HistoGeneX chooses Quality by Design for quality assurance
- Eudralex Vol 4: New annex 15: Qualification (PART 2)
- Pharmaceutical industry: compliancy doesn’t always equals quality
- QbD in the United States: work hard, play hard
- Medical device legislation: how to keep up to date
- EudraLex Vol 4: New Annex 15: Qualification
- Vaccinating: a new key role for pharmacists?
- QbD’s foot in the door
- High quality, low risks: how to optimize pharmaceutical and medical quality control management
- Draft paper on new EMA guidance for importers of medicinal products
- Harmonised Guideline For Elemental Impurities
- Good Distribution Practices (GDP)
- Combination products – deel 3
- Combination products – deel 2
- Un San Valentín de calidad
- Combination products
- Nieuw bij EMA (3)
- Nieuw bij EMA (2)
- Wat is ANDA?
- Nieuw bij EMA (1)
- Japanse Pharmacopoeia en GMP-regulaties
- Nieuw bij FDA (3)
- Nieuw bij FDA (2)
- Nieuw bij FDA (1)
- Nieuw in de GMP-wetgeving van EMA (2)
- Nieuw in de GMP-wetgeving van EMA (1)
- EMA publiceert GMP black list
News
- The QbD Group appoints new COO and Senior Director Integration to further align the Group’s international activities and acquisition integration processes
- QbD Group requalifies as Best Managed Company
- TRIUM Clinical Consulting is being rebranded to QbD Clinical
- Quality by Design (QbD) becomes QbD Group
- QbD acquires marketing & communication agency ‘Monkeys not Donkeys’ to strengthen its services within the life science industry.
- New office and strengthened team for QbD Wallonia
- QbD and Inovigate launch Health to Market, a contract commercialization organization in life sciences
- Quality by Design continues to grow: welcome Qarad!
- QbD Software Announces Major Rebranding: Scilife is Born.
- New partnership: QUERCUS Labo (QC) joins QbD Group
- Kanaal Z episode about QbD
- Quality by Design and TRIUM join forces
- QbD selected ‘Best Managed Company’ by Deloitte – Interview with CEO Bart Van Acker
- Bart van Acker (Quality by Design) named Flemish Young Entrepreneur of the Year
- QbD at Knowledge for Growth 2014
- Limoncello to a top-quality year
- New job announcement: consultants and project engineers
- Quality by Design in the launch issue of MARK Magazine
- Unique collaboration with Wase Werkplaats and Kunst+
- Quality by Design opens office in Leiden
- QbD whitepaper: Technology Transfer Needs a Lingua Franca
Vacancies
- Senior Recruitment Expert
- Laboratory Manager
- Office Assistant
- Regulatory Affairs Specialist – ATMP
- Business Developer Life Science
- Clinical Regulatory Manager
- Accountant
- Performance Evaluation Studies Expert
- Lead Commissioning & Qualification SME
- Project Manager Quality Assurance
- Regulatory Affairs Specialist – Medical Devices
- Device Compliance Expert
- Authorised Representative Specialist
- Talent Acquisition Specialist Flanders
- Business Developer Flanders
- Talent & Business Partner – QbD Spain
- Clinical Trial Assistant
- Medical Regulatory Writer
- Account Manager
- Senior Project Manager Life Sciences
- Regulatory CMC Writer
- Clinical Project Manager
- Clinical Research Associate
- Business Developer Life Sciences – Nederland
- Process Engineer
- Computer system validation (CSV) consultant
- Young potential
- Project engineer pharma & life sciences
- Freelancer Farma / Biotech / Medical Devices
- Project manager life sciences
- Regulatory affairs consultant
- Medical Device Specialist
- QC (quality control) method validation professional
- Qualified Person (QP) – industrial pharmacist
- Technology Transfer Engineer