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:
QbD takes care of your short-term and long-term projects in the field of validation, regulatory affairs, quality assurance and project management. We deliver clearly defined results within a specific time frame and budget to our customers.
To optimally support your projects, we make use of a structured approach for project management. After your request, we start with a Quick Scan to gain insight into the specific problem definition, perform a gap analysis and create a CAPA list with critical actions. Based on the Quick Scan, you decide what kind of support you need: coaching or complete project execution.
In the case of coaching, one of our senior experts will support your organization. In addition, you have access to our internal operational resources. If we take care of your whole project, project execution consists of a kick-off meeting, weekly working committees and monthly steering committees. You will be supported by a dedicated team, including a senior project manager and a team of junior engineers.