The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.
Maintaining computerized systems during the operational phase is critical to the proper functioning of organizations. In this article, we explore some of the best practices for doing so.
Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
Struggling with CSV validation and testing automation? Tired of re-validating at every sprint? Discover expert tips to reduce time, and budget, and increase validation coverage in our latest blog post on automated software testing for the GxP world.
In this blog post, you will learn more about analytical method validation and the criteria to consider when validating your analytical method.
Although manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last minute. Learn how to plan MDR compliance for your medical device here.
The UK government introduced the Innovative Licensing and Access Pathway (ILAP) in 2021 to give patients quicker access to cutting-edge treatments and therapies by offering a streamlined approach to licensing and regulatory processes. Learn more about ILAP in this blog post.
QbD Group Ltd. attended the MHRA GMDP symposium, a highly anticipated annual event that brings together stakeholders in the pharmaceutical industry to discuss the latest trends and developments. Discover our insights here.
Want to introduce robustness into your software validation activities? In this article, you will learn what the Agile model is and how to use the GAMP 5 framework for agile development.
The EU GMP Annex 1 Manufacture of Sterile Medicinal Products was revised in 2022. In this blog post, we will provide a summary of the changes and our initial insights several months after the revision.
Annex XVI of the MDR EU 2017/745 lists products without an intended medical purpose that now fall under the MDR. In this blog post, you will learn more about the contents and requirements of the annex.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new IT system to streamline submissions related to product licensing and process licensing. The first release of the system is expected by the end of 2023, with subsequent releases incorporating wider elements such as medical devices and import notifications. An agile delivery model will enable continuous improvement based on user feedback.
Regulatory agencies impose internal audits and supplier audits in the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing Practices and ISO standard requirements. These audits help identify potential problems that may affect product quality, efficacy or safety, and provide a mechanism for implementing corrective actions to minimize public health risks. In this blog post, we’ll discuss 7 key areas to focus on during internal or supplier audits.
Learn 8 logical steps to take prompt action when national competent authority inspection reports, EIRs, FDA Forms 483 or warning letters show non-conformities. Failure to act can have crippling consequences.
In celebration of International Women’s Day, we sat down with Elly De Bruyn, Chief Human Resources Officer (CHRO) at the QbD Group, to talk about her experiences and views as a power lady in the life sciences industry.
Learn how digital health is transforming clinical trials. Explore the benefits and challenges of implementing digital technologies.
Want to introduce robustness into your software validation activities? In this article, you will learn what the GAMP 5 V-model is and the key steps within it.
This blog post provides an overview of essential documents required during medical device clinical investigations in accordance with ISO14155:2020.
The European Parliament has approved a proposal to extend the transitional deadlines for certain medical devices under the MDR to ensure availability of devices whose certificates have expired or will expire before 26 May 2024. Manufacturers must adhere to specific conditions to comply with the new transition periods. Learn more here.
Are you about to qualify your laboratory equipment? If so, here are the key considerations and challenges to consider.
Each individual medical device must have a Unique Device Identifier (UDI) with its carrier (barcode or QR code). But what about medical device software? Read the answer in this article!
Can the computerized system validation used in pharma be applied to non-product medical device software? In this article, we compare ISO 80002-2 with GAMP5 to find out.
In 2023, the IVD industry will continue to dominate the medical technology market due to rising demand for early diagnosis, treatment and point-of-care testing. Product trends include the accelerated consumerization of diagnostics, the rise of telemedicine and digital health, the growth of devices enabling personalized medicine and the emergence of AI and robotics-powered medical devices. Medical device manufacturing will undergo changes in the computerized system validation process due to the increased focus on critical thinking by GAMP5 and FDA.
In this article, you will learn a structured approach to ensure regulatory compliance and proper operation of your computer systems, throughout their life cycle.
December is often symbolized as the ‘Month of Giving’ as it revolves around giving something back to society, helping others and spreading joy. Supporting good causes is one way we put our company value ‘joy’ into practice at the QbD Group. Let’s highlight a few of them!
Artificial intelligence (AI) and machine learning (ML) are on the rise in the medical device and IVD industry. Learn more about the current landscape and regulatory framework here.
Learn more about the importance, benefits, and key challenges related to Annual Product Quality Review in Pharma.
Job fair season is upon us! Whether you’re looking for your first job or a new work adventure, we can all agree that applying for a job comes with a healthy dose of nerves. To make sure you are the best version of yourself, preparation is key! Want to succeed in your next interview and land your QbDream job in consulting? Put your foot in the door and kick it wide open with these 5 tips!
Bringing a Medical Device to market involves many hurdles, including design and development. In this blog post, you will learn more about the importance of Design Transfer and Process Validation in medical device development.
Today, on Nov. 14, 2022, we proudly received the Baanbrekende Werkgever ’23 certificate for the second year in a row, representing our commitment to put our employees at the center of our policies around hybrid work and mobility.
Digital health is on the rise, but what is digital health exactly? In this blog post, we’ll explore the landscape, key technology pillars and future opportunities.
21 CFR Part 11 regulates the use of electronic records and signatures in pharma and medical devices. Want to comply? Read more below and download our 21 CFR Part 11 compliance checklist.
Discover 5 reasons to engage with an experienced Contract Research Organization (CRO) specialized in medical device studies to support you in your clinical research.
It is important to understand how standards are written and how their references are constructed in order to properly reference them and purchase the correct version for your use.
In this blog entry, we explain the difference between ISO and IEC standards, what harmonized standards are, and how to use the appropriate standard references in your technical documentation. We also give you a hint on how to make sure you have identified all applicable standards for your products.
Want to learn more about the difference between Artificial Intelligence and Machine Learning and/or need insight into the right validation strategy for your AI- or ML-based systems and products? Read more here.
Have you validated your computerized system(s) yet? Then CSV Periodic Reviews are an important next step. Learn more about their purpose and frequency here.
The quality of process gases and gas distribution networks is becoming increasingly important for biotech pharmaceutical processes and ATMP sites. In this blog, we highlight the importance of a qualified process gas and distribution network, even at an early stage of development.
In 2022, ISPE released a new, second edition of the GAMP 5 guide. Read more about this new edition here and/or watch our webinar on demand.
Self-inspections or internal audits are an essential part of your QMS. In addition to determining whether your QMS meets guidelines and standards, you can benefit from them in several ways. They allow you to get to know departments better, explain to people why certain quality processes are necessary, gather useful feedback for further improvements to the QMS, and you have a tool to check your readiness for external audits.
Are you a manufacturer of custom-made medical devices and in need of regulatory guidance? This article summarizes key concerns to consider.
In Belgium, medicine advertising is subject to legislation in order to ensure the rational use of medicines. Each firm must appoint a Responsible Person for Information and Publicity, who checks the conformity of the advertising.
The Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Device Regulation (IVDR) (EU) 2017/746 introduced a new mandatory role in Article 15: the Person Responsible for Regulatory Compliance or ‘PRRC’. Wondering what the meaning of the PRRC-role is and where you can find the right person? Then read on!
Considering an exciting career as a life sciences consultant, but still in doubt? In this article, we debunk 6 myths about consultancy to help you decide!
Compressed air and other process gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in direct contact with products to clean, aerate, or move them through the processes or the using process gases in fluid pumps that take products through the production and filling processes. Compressed gases, such as nitrogen or argon, can also be used for blanketing or to spray or coat a product. The risks associated with the use of these gases, depend on the amount and type of product contact and based on this risk assessment, a suitable monitoring plan should be in place.
At the QbD Group, we want to take into account the opinion of our employees. Therefore, our Board of Ambassadors was elected to represent the voice of all QbD’ers, within and outside of the group. Thomas Van Looy has been elected as one of our Ambassadors for 2022. Congratulations, Thomas! As an Ambassador, he loves to share his QbD Group experiences. Want to find out more about Thomas’ #QbDream job? Then don’t miss out on the interview below.
Sometimes it is necessary to perform data migration in computer systems, applications, or software. Learn more about the goal, importance and risks here.
At QbD, we value the opinion of our employees. Therefore, QbD’s Board of Ambassadors was formed to represent the voice of all QbD’ers, across the QbD Group and across all borders. Catarina Cruz has been elected as one of our Ambassadors for 2022. Congratulations! As an Ambassador, Catarina loves to share how she experiences working at QbD. Want to find out more about her #QbDream job? Make sure to read the interview below.
On August 21, 2022, the new GMP Annex 21 will enter into force. This Annex contains the GMP requirements for MIA holders when importing medicinal products from outside the EU/EEA. Learn more here.
To document the clinical evaluation of your device and its output, a Clinical Evaluation Report or CER has to be compiled. Learn more about this key document, its content, common gaps and hurdles.
During the pandemic, electronic signatures gained tremendous importance for companies in the regulated sector. Learn more about electronic signatures, their use and safety here.
The Clinical Evaluation Plan, or CEP, is a crucial starting point and guide for the clinical evaluation of your medical device. Learn more about this key document and its requirements.
In CSV, decommissioning is the retirement or controlled shutdown of an IT solution or computer system that is no longer needed. Learn more about this process here.
Steven Vinkx has been working for QbD for 10 years now, and counting. Congratulations! Curious about his career and insights? Then be sure to read this interview!
Clinical evaluation of medical devices is critical to obtaining and maintaining marketing approval in the EU. Learn more about clinical evaluation here.
A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA simplifies the review process for authorities and the submission procedures for industry. However, with the upcoming changes to the EU pharmaceutical legislation, the CEP procedure may be at risk. In this blog post, we outline the possible changes in the near future.
CAR-T cell therapy uses genetically engineered T cells to destroy tumor cells. Learn more about the main components, manufacturing process and prospects of this promising immunotherapy.
Dominiek Rossillion has been working for QbD for 10 years now, and counting! Our heartiest congratulations! Curious about Dominiek’s career and insights? Then be sure to read this interview!
The new medical device regulations and the associated implementation of EUDAMED are intended to give the general public access to relevant information on medical devices, ensuring greater transparency. However, EUDAMED also brings new requirements for market participants throughout the life cycle of medical devices. Read more about them here!
GAMP categories are very important to decide on the validation strategy of your computerized system. Learn more about all categories here.
10 years! That’s how long Katrien Janssens has been working at QbD now. Congratulations! Curious to know how Katrien has experienced the past decade at QbD? During a brief interview, we asked her 10 quick questions: one for each year she has worked with us!
3D printing offers unrivaled flexibility and personalization in medical devices as illustrated by the case of Joe DiMeo’s face and hand transplant. Curious? Be sure to read on!
Regulatory Affairs plays a key role in the pharmaceutical industry: from drug development to commercialization. Learn more about the roles and functions that RA teams can provide in the lifecycle management of your pharmaceutical product.
Sampling, testing, and preserving your medicinal product in closed systems often present difficult Quality Control challenges. As part of the solution, various AI-based in-process controls can be used. Discover them here!
Medical devices are one of QbD’s main areas of expertise. We support you from concept to launch in the full life cycle. Wondering what a day in the life of a QbD MD Specialist looks like? Let’s take a look behind the scenes!
Cell therapy includes various ATMPs to fight tumors or restore the physiological status of damaged tissue. Explore them here.
If you know that QbD was founded 10 years ago, then it won’t come as a surprise to you that the 10Y anniversary of an employee is an EXTRA big deal to us. After QbD founder Bart (obviously), Jeroen Verhoeven is the very first employee to reach that landmark.
In order to give this news the attention it deserves, we fired 10 questions at Jeroen, one for each year he’s been with us!
On November 15, 2021, QbD and TRIUM received the Baanbrekende Werkgever ‘22 certificate for pioneering Belgian employers striving to put people at the center of their policies on hybrid work and mobility.
Dendritic cells play an important role in recently developed DC-based immunotherapies for the treatment of cancer, autoimmune diseases and the prevention of graft rejection. Read all about DC cells and their potential in this article.
NK cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy.
Curious about the potential of NK cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.
In the EU, the IVDR will replace the IVDD. The compliance deadline is approaching, so act now to obtain CE marking of your IVD medical device in time.
Follow these steps before launching medical device combination products in the EU, including the application of MDR Article 117 and the EMA Directive.
Learn more about the new risk-based approach to in-vitro diagnostic device classification under IVDR 2017/746, replacing outdated directives.
The introduction of MDR impacts CE-marked medical software (MDSW). Curious about the scope of this impact on your software? Read more below.
Curious about the latest medical device industry trends? Learn more on wearables, AI, POC testing, IoT, and more in this blog post!
The QbD Academy is a young graduates program that combines working, learning and intensive training. Last month, we welcomed 15 young graduates during our QbD Academy Week. Read all about it here!
Artificial Intelligence is the IT word in Medical Devices nowadays. Learn more on AI and its regulatory implications for manufacturers.
The terms SaMD (Software as a Medical Device) and MDSW (Medical Device SoftWare) are often used interchangeably within medical environments, but they are not. Learn the difference in meaning and regulatory scope here.
Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical devices on the UK market here.
ATMPs are a promising new type of medicine. Learn more about the challenges in translating the expertise into a GMP process.
Sports have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge! Read all about it here.
Whether your product is a medical device depends on the markets you want to enter and their regulations. Here’s an overview to guide you.
Risk management, the key to medical device safety, involves much more than ticking the FMEA box. Jeroen Verhoeven, one of our specialists in the matter, explains why and guides you through the ISO14971 standard (application of risk management to medical devices).
At QbD, we’re going the extra mile to put hybrid working to everyone’s advantage after COVID-19. Need some inspiration? Follow our lead!
ATMPs are, by nature, highly complex and innovative therapies. And well-designed clinical trials are key to producing effective and safe ATMPs – ultimately increasing patients’ health and speeding up market authorization. In this blogpost, Marie-Paule Gyselen from TRIUM Clinical Consulting (part of the QbD Group) guides you through the most important ATMP-specific clinical trial challenges.
Launching a medical device requires much preparation. As these devices are heavily regulated, a company has to meet many requirements in different phases of the development and manufacturing process. Which phases are there to consider and what are their characteristics? This blog digs deeper into the lifecycle of a medical device and requirements that must be met in those phases.
Not sure where to start when validating your computerized systems? Follow these 10 steps as a guideline.
In the smart factories that came with Industry 4.0, digital twins of manufacturing processes are key to improving process robustness, development lead times and ultimately reducing costs. In this blog Evan Claes and Tommy Heck from our partner Antleron explain how digital twins work and why they are so vital, especially to ATMP manufacturing.
In this blog post, we give more insights into the challenges a QP faces when dealing with ATMPs. We talk about sterility, out-of-specification handling, batch release, and EU import testing.
The sales price of cell and gene therapies is influenced by multiple factors like Cost of Goods (COG), regulatory requirements, target market (or commercial aspect), and the development just to name a few. In this blog post you will learn more about the GOC aspect: what is this cost comprised of and how can you reduce it?
UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a manufacturer, you need to make sure you’re UDI-ready in time.
During the QbD Corona World Games, our online international team building event, thirteen randomly selected teams defended their honor.
A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical
One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by leveraging the
Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the
Among the Advanced Therapy Medicinal Products (ATMPs), in the immunotherapy market, nowadays two acronyms catch the eye: CAR-T and TCR-T. The two techniques are based
It’s obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build
GxP Processes Without question, the impact of GxP processes such as product quality and patient health are at the top of the list when it
What does an automation pyramid entail? An automation pyramid visualises the integrated layers of technology used in manufacturing or industry combined with the level of
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Have you read our earlier blogposts about the The importance of a dedicated team and skilled project manager for technology transfers, the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
