Day by day our consultants rely on very specific expertise and experience to meet the varying challenges of their clients. That is why proactivity is so important. QbD takes great care to maintain this standard of expertise across industries and regulations. A nice example of this are the competence centres: 4 knowledge hubs, motivated by the drive to share and maximise QbD expertise.
The initiative took off in 2013 and has expanded organically. Each competence centre tackles a specific topic from a wide angle. They are inspired and run by a group of internal experts. Every employee is invited to opt-in for the fields they’re interested in. The 4 competence fields are:
- Quality by Design Framework
- Quality Assurance and Audit
- Engineering & Quality/Validation
- Computer System Validation
Hannelore Declercq is one of the driving forces of the Engineering & Quality/Validation centre. She’s an ideal guide to introduce us to the ins and outs of the QbD competence centres. Hannelore works as Pharmaceutical Project Engineer at the Pfizer product support department. She got involved in the equipment qualification and validation competence centre since the start of her career at QbD.
“Get smarter while sharing QbD expertise, create QbD tools and best practices while making fun.”
Both seniors and juniors benefit from this exchange of up-to-date know-how and best practices. “Participation is free of course. All QbD colleagues can join in based on their specific needs and interests. In addition, together we form an enjoyable and enriching knowledge framework. In a relaxing atmosphere we share valuable experiences and insights. We discuss trends and innovations and build on each other’s expertise. Moreover, we develop new trainings and tools. Sometimes we invite experts in different fields or departments to highlight specific topics”, explains Hannelore.
“The review role of our compliance centres is essential”, adds Hannelore. “The knowledge is often based on pragmatic experience achieved throughout activities and projects for clients. This know-how is centralized in our database. There it is easily accessible for consultants confronted with a specific project or challenge.”
In the process, QbD is building a rich knowledge base covering many angles:
- Follow up on new trends and technologies in the life sciences.
- Share knowledge on new regulations and guidelines, best practices, customer cases…
- Create and update templates and guidelines. Store and standardise them via QbD’s quality management system ‘QualityKick’.
- Give QbD consultants access to an up-to-date database with the most effective guidelines and protocols for the various procedures and systems.
- Create knowledge hubs for open dialogue and innovation
Wide range of activities
The competence centres offer much more than a casual meet-up of experts. A vital objective of the QbD competence centres is furthermore to bring consultants and clients up to speed in the various fields of expertise through specialized trainings. Hannelore gives two examples: the basic ‘QualVal’ day training and the Audit & Compliance workshops. These are coaching sessions for QbD consultants by experienced colleagues. Day trainings are also made available for clients wishing to acquire specific knowledge on quality and validation of equipment. Since 2013 the competence centres have grown in number, topic range as well as national boundaries. They will continue to do so in the coming months.
Contribute to or tap into the know-how of the QbD competence centres? Please contact us for more information.