The life sciences industry (biotechnology, medical devices, pharmaceuticals, cosmetics, health, …) is constantly evolving. Therefore, it’s crucial for companies to stay on top of things and to react to these changes in a flexible and practical way. The best way to do this? Through internal and external knowledge sharing, which has always been one of QbD’s priorities. In order to obtain the best results for QbD and our clients, we’ve implemented competence centers and thinktanks.
Competence centers for knowledge sharing are small discussion groups, led by our own people, in which we brainstorm about a certain relevant topic.
At QbD, four different competence center groups come together four times a year after office hours, mostly at our HQ in Wilrijk, but also at a client location. Sometimes, we invite guest speakers from one of our partners, but our main focus is on internal information and knowledge sharing. In general, more than half of our consultants attend these discussions on a regular basis.
Each competence center evolves around one of the main domains we offer services in: Qualification and Validation, Computer System Validation and Data Integrity, Quality Management and Medical Devices.
These competence centers have a double added value: they’re an investment in our consultants on the one hand, and beneficial to our clients on the other.
Our competence centers help to keep our consultants up-to-date on new trends and topics. If you’re a consultant working for a specific client, you don’t always cover multiple knowledge domains when executing a certain task. During our sessions, consultants get the opportunity to share what they’ve learnt during their time at a certain company. That way, they expand their general industry knowledge and are able to inspire each other to come up with new solutions to benefit the client. Moreover, with our Academy Model in mind, it’s a great way for them to pimp their resumes and to put themselves on the market for new positions after finishing a project. And for our competence center leaders it’s the perfect way to really claim a field of expertise.
The fact that our consultants continue to broaden their knowledge is also extremely valuable to our clients. In fact, our competence centers can be considered as an extra form of training, on top of the training they already get. Also, clients often approach us with a specific problem, regarding data integrity or fraud for example. In those cases, we discuss the situation during our sessions, which allows us to look at it from different perspectives and to come up with a solution together.
Here, you can meet our competence center groups for knowledge sharing:
This domain entails a very large part of our business. But how do we differentiate ourselves from other companies? Although there are many fixed templates and procedures available to use, qualification and validation requires people with the right insights to obtain the most accurate results. And that’s exactly what we’re working on in this competence center: together, we broaden our horizons by sharing experiences and discussing topics within the different qualification domains: IQ/OQ/PQ, Process, Cleaning and Method Validation, ATMP’s, and many more. As a result, we train our consultants to become deployable at any client, no matter the kind of approach they use. We also make sure every QbD’er is able to set up an individual validation approach for clients that don’t have any prior knowledge about the matter.
How can you make a computer system ‘compliant’ in a validation critical context? That’s the main question we ask ourselves in this group. Our goal: to provide the appropriate knowledge of legislation, norms and guidelines that are needed to stay up-to-date within the world of computer system quality.
In contexts that require regulation, computer systems need to comply with strict conditions. Validation approaches are always conducted in the prospect of data integrity and the limitation of risks, which requires multiple documents and procedures. Recurring tasks within this domain therefore include computer system tests and giving compliancy trainings.
Legislations are becoming stricter, and the situations in which we have to apply those laws for our clients are getting more specific. This requires the right amount of insight from our employees, combined with a great portion of creativity and flair – which we’re practicing in this competence center. During this discussion, we also cover the latest Quality Management innovations and the most recent relevant regulations, and we put all the quality systems into practice.
The Medical and IVD (In Vitro Diagnostics) Devices market is evolving quickly. On the one hand, more personalized therapies need to be set up, and the demand for accurate diagnostics continues to grow. On the other hand, regulations are becoming more and more strict, resulting in multiple adaptations in the aspect of quality and regulatory management. Since this is such a complex domain that serves as one large denominator to cover different elements, it’s important to gather all the info on the latest Medical Devices and IVD’s in the market – such as the changed classification based on the European guidelines, the impact on the quality system and the effect on regulatory compliancy. We usually do this through different themes and trends, which our QbD’ers are free to introduce.
Aside from our competence centers, we also organize thinktanks four times a year – also after office hours. The main difference here is that the main goal is to share knowledge on an external level. Each thinktank is centered around a specific topic; recent examples are 3D printing, ATMPs and Regulatory Affairs. These events are meant for a larger group of QbD-employees and include presentations by different speakers, each approaching the chosen topic from another angle. We also aim to take on a very interactive approach, in order to continue to share different opinions and perspectives with each other.
And since network = knowledge, we also use the full networking opportunities of our Thinktanks. Before and after the presentations, our colleagues and the presenters have plenty of opportunity to talk to each other while enjoying a snack and a drink. Once or twice a year, we even organize a Thinktank XL, inviting clients and other external participants. Feel like joining a Thinktank XL someday? Then don’t hesitate to let us know, we will keep you posted on the dates and topics.
Want to know more about our competence centers or our think tanks? Or do you want to know what our knowledge and expertise can do for your company? Then don’t hesitate to contact us.
Since we’re a knowledge organization, we have an enormous amount of knowledge in-house. To keep an overview from all that knowledge and to keep all those different knowledge-sources under control, we have our Knowledge Manager. How he does that, you can read on our news section.