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- Eerste werkervaring achter de rug? QbD geeft je ruimte om te groeien.
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- Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems
- Medical devices: urgent needs vs regulation
- The Medical Device CE Certification Pathway Explained
- ATMPs: Regulatory Do’s and Don’ts
- Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems
- ATMP Quality Management Systems: Strategies for Compliance and Success
- Medical Devices Risk Management according to ISO 14971:2019Â
- Computer System Validation courses 2022
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Blogs
- MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK
- Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations
- CE approval for Medical Devices under MDR: key requirements for your device class
- Qualifying a New GMP Facility: From Pitfalls to Best Practices
- Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects
- Importing medicinal products into the EU? A Brief Guide to EU GMP Compliance.
- Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto
- Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSAÂ
- Understanding plasmids: small molecules with big implications
- Oncolytic viruses: the use for cancer immunotherapy
- Paperless Validation in Pharma: embrace the future
- GMP-compliant design of climate or stability chambers: the key to ensuring product integrity
- Regulatory guidelines for stability testing: a brief overview
- State Of The Art Literature Review – Process and Documentation
- 4 Factors Influencing the Stability of Medicinal Products
- Digital Health in Pharma: Revolutionizing the Industry from R&D to Patient Care
- Mastering Cleanroom Qualification: navigating the latest regulatory updatesÂ
- Computerized System Validation in clinical trials: key considerations
- State of the Art (SOTA) Literature Review – What, Why, When, and Who?  Â
- The Importance of Stability Testing in Pharmaceutical Development
- Pharma 4.0: The Future of Pharmaceutical Manufacturing
- Clinical Literature Review – Common Gaps and Hurdles to Take
- EudraLex Volume 4 Annex 11: compliance checklist and future prospects
- A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU
- The EU Commission Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry
- How to keep computerized systems in the operational phase?
- Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare
- Automated software testing for the GxP world
- Analytical Method Validation: are your analytical methods suitable for intended use?
- MDR transition: how to plan MDR compliance for your Medical Device?
- ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway
- MHRA GMDP Symposium: key insights, trends, and best practices
- What is the Agile model in Computerized System Validation?Â
- EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights
- MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS)Â
- UK’s medicines regulator announces IT roadmap
- 7 key areas to focus on during internal or supplier auditsÂ
- 8 steps to successfully respond to non-conformities in an inspection report Â
- Celebrating International Women’s Day with power lady Elly De Bruyn, CHRO at the QbD Group
- Introduction to Digital Health in Clinical Trials
- What is the GAMP 5 V-model in Computerized System Validation?Â
- Essential Documents in Clinical Investigations with Medical Devices: a brief overview
- The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical DevicesÂ
- Qualification of laboratory equipment: key considerations and challenges
- UDI for software: how to mark your MDSW with a UDI?
- Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?
- Medical Device and IVD industry trends for 2023
- Change Control Management: how to keep your systems compliant?
- Helping others is what brings the QbD Group joy every day
- The Advent of Artificial Intelligence and Machine Learning in Medical Devices
- Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges
- 5 tips to score a job as a Life Science consultant
- Medical Device development: the importance of Design Transfer and Process Validation
- QbD Group awarded Baanbrekende Werkgever ’23 certificate for the second year in a row
- What is digital health? Exploring the landscape and future opportunities.
- 21 CFR Part 11 compliance checklist: does your system comply?
- 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
- GAMP 5 Guide 2nd Edition: what’s new?
- 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
- PRRC under MDR and IVDR: 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
- 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 strategyÂ
- What is decommissioning in CSV?
- Clinical evaluation for medical devices under MDR: a brief guide
- EDQM and the CEP of the futureÂ
- CAR-T cell therapy: main components, manufacturing, 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 medical devices: enabling patient-specific solutions 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
- 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 (DC) cells: effective sentinels for immunotherapies
- Natural Killer (NK) cells: 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
- What is a medical device? Key definitions and regulations around the world.
- 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
- Post-Market Surveillance of Medical Devices
- Medical devices: innovations versus regulations
- Is your ATMP platform robust enough to deal with material input variability?
- 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 importance of a dedicated team and skilled project manager for technology transfers
- How to start with computer system validation?
- Tech transfer: what are the drivers of complexity?
- Technology transfers: these factors can make or break them
- 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 QbD life of… Frederick Tison – Corona times
- Anything you need to know about ATMPs: FAQ
- 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?
- 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
- Belgium as pioneer in ATMPs: now and in the future
- Technical writing: the importance, do’s and don’ts
- Market introduction of new medical devices: submit under MDD or MDR?
- 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?
- Pioneering with Artificial Intelligence to make personalized cell therapy more accessible
- Updating Good Clinical Practice E6(R2)
- Preparing for growing challenges in pharmaceutical serialization
- Antleron & QbD team up to create a landslide in healthcare
- Data integrity in the pharma industry – a short introduction
- Eudralex Vol 4: New annex 15: Qualification (PART 2)
News
- Bart Van Acker established a Chair after close friend suffered from glioblastoma, an aggressive form of brain tumor
- QbD Group colleague Salma Michor named RAPS Fellow 2023
- The QbD Group acquires life sciences consultancy Azierta to reinforce its global vigilance services and expand its presence in Spain
- Belgians send miniature heart into space for ageing research
- The QbD Group acquires Turnstone Communications to strengthen its specialist science communication and business development services
- The QbD Group acquires Michor Consulting to enhance its regulatory affairs services across Europe
- QbD Group awarded Deloitte’s Best Managed Company Gold Label
- QbD Group Foundation: anchoring our social commitment
- Monkeys not Donkeys, QbD Group’s life science marketing and communication agency, strengthens its team
- The QbD Group acquires regulatory affairs and pharmacovigilance company EUDRAC Ltd. to expand its services for pharmaceutical customersÂ
- Qarad’s eIFU services rebranded to ‘IFUcare’
- 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
- Stagiaire en Ressources humaines
- Junior Business Development Manager Wallonie
- Consultant Regulatory Affairs Pharma
- Snr business development manager (NL)
- Laboratory Planning Coordinator
- QA Officer
- Quality Assurance (QA) consultant ATMP
- Global Sales Specialist – Industrial Toxicology (Pharma Focus)
- Sr. Business development manager medical devices/IVD -China
- Senior Business development manager Wallonie
- Division Head – Regulatory Affairs
- Medical Device/IVD Software Specialist
- Senior Operations Lead, Clinical Division
- RA Specialist CMC
- RA Specialist China
- Business Development Manager
- Associate Director Regulatory Affairs
- Finance Manager
- Senior Expert IVD
- Associate Director/Director Regulatory Affairs
- Sr Business Development Manager – Clinical
- Quality Manager
- Senior Business Development Manager UK
- Regulatory Affairs Consultant IVD
- ATMP Specialist
- Principal Regulatory Consultant
- Senior Business Development Manager Medical Devices
- Regulatory Affairs Specialist – ATMP
- Performance Evaluation Studies Expert
- Project Manager Quality Assurance
- Regulatory Affairs Specialist – Medical Devices
- Expert IVD
- Authorised Representative Specialist
- Clinical Trial Assistant
- Medical Writer
- Regulatory CMC Writer
- Clinical Project Manager
- Clinical Research Associate
- Process Engineer
- Computer system validation (CSV) consultant
- Jóvenes profesionales
- Jóvenes profesionales
- Ingeniero de proyectos en industria farma y afines
- Ingeniero de proyectos en industria farma y afines
- Consultor en gestión de calidad
- Consultor en gestión de calidad
- Project engineer pharma & life sciences
- Freelancer Farma / Biotech / Medical Devices
- Validation & qualification consultant
- Project manager life sciences
- Medical Device Specialist
- Consultor para validación de sistemas informatizados (CSV)
- Consultor para validación de sistemas informatizados (CSV)
- Qualified Person (QP) – industrial pharmacist