As you may have already read here, QbD is the reference in consulting in many different life sciences industries (pharma, biotech, cosmetics, medical devices, …) and fields of expertise (quality management, validation, tech transfer, ATMP, …). But what if you suddenly have a specific challenge? How does QbD tackle that on a project management & support level? What can you expect from us once you decide to start a project with Quality by Design?
First of all, we start by listening very thoroughly to your needs and challenges. Do you want to implement a Quality Management System, or upgrade from ISO 9001 to a higher standard like ISO 13485? Or would you like us to perform all your requalifications? Whatever your request may be, QbD always realises that each specific challenge and client is unique.
That’s why we always start with a visit. That enables us to determine the scope of the project. This visit includes a quick scan, which consists of an interview with different stakeholders, and finally an audit which tells us – and you – to which extent you currently comply with existing norms and procedures. The result is a detailed report, which includes all the steps that are required in order to meet your needs. This report is then translated into a plan with budgets, timings and roles.
If you decide to execute the above mentioned plan with our help, QbD offers two possibilities, depending on the project scope and your own available firepower:
If you have all the resources (such as enough staff and expertise) to execute the plan yourself, we assist you mainly with advice where needed. We act as a coach and sparring partner. If you have questions on how to implement something, our expertise and market knowledge is at your disposal.
If you don’t have those resources, or if we’re talking about a very extensive project, we advise you to hire an on-site QbD team to maintain the most qualitative and efficient result. This team will be led by a senior expert / project manager. QbD has the right in-house specialists for you, who all are part of an extensive QbD expertise network, thanks to our continuous focus on knowledge management. This team will blend perfectly with your own resources and people. After the ‘kick-off’ meeting, this collaboration is streamlined and followed up during different committees. During the weekly working committee, the most important executive topics are discussed: status, planning, who-does-what, … Once a month, the steering committee comes together to talk about the project on a higher level, which can include scope changes for example. And finally, six months after completion of the project, we set up a review meeting to discuss if everything is still performing as it’s supposed to, and to discuss possible additional challenges.
But like we said, each client and each project is unique. So we tailor our project management to your specific needs, ranging from remote advice to the in-house deployment of a large team, or even a hybrid approach.
Whichever road we decide to take, we guarantee you a professional partnership with the best possible consultants that are prepared to go the extra mile for you. So that no matter what, things get done. Without ever forgetting that a big dose of joy always gives you – and us – a head start. Learn more about our corporate ‘JPEG’-values here.
Are you in need of on-site consultants on a more permanent basis? QbD can definitely help you out here! Want to know more about that, then don’t hesitate to let us know.