In the world of life sciences, ensuring the safety and efficacy of products is paramount. Qualification and validation projects play a pivotal role in guaranteeing that pharmaceuticals, medical devices, and ATMPs meet stringent regulatory requirements.
At the QbD Group, we understand the difficulties of these projects and deliver successful qualification and validation projects with the expertise of a seasoned project manager and a highly skilled project team.
In the past, we managed several qualification and validation projects encompassing newly built labs and production facilities. Learn more about our Project Management Process.
Figure 1: QbD’s Project Management Process for Qualification and Validation Projects
Step 1: Project Initialization
Every successful project begins with a solid foundation. Based on the tender or proposal, the project manager kicks off the project with an overall kick-off meeting and individual kick-off meetings for each work package if applicable.
During these meetings, we listen closely to our customers to further understand the scope, requirements, goals, constraints, and intricacies of the project. and the role and tasks of the QbD Group and all involved client staff are discussed.
We also divide the project into manageable work packages, ensuring clarity and efficiency in project execution. For each work package, a QbD work package leader and a client single point of contact (SPOC) are defined to improve communication (one point of contact for each team).
Step 2: Creating a Project Plan
With a clear understanding of your project’s scope and goals, we move on to the crucial step of creating a comprehensive project plan. Leveraging project management tools, we track activities and maintain an overall project plan that guides us throughout the project’s lifecycle.
The tool allows for real-time updates and ensures transparency towards customers in performed activities. Within a project, it is important to follow up on four factors: scope, budget, quality of work, and timelines.
This project plan also includes a communication plan. We believe that excellent communication is one of the main drivers of successful projects and that short communication lines are crucial.
Based on the experience that we have built up from projects, strong interactions between QbD as a service provider and the client are indispensable in working towards a common goal. This will create a “one-team” mentality, resulting in quality projects completed on time.
Step 3: Periodic Steering Boards
Effective communication and oversight are paramount to project success. During periodic steering board meetings with all sponsors, we discuss issues, risks, budgets, and timelines, all of which are closely aligned with the project plan and budget reports.
These meetings serve as a platform for collaborative problem-solving and risk handling, keeping the project on track and within budget. Constant team meetings and communication ensure everyone is on the same boat when it comes to the actual execution of deliverables and actions.
Step 4: Project Execution
With a solid plan in place and ongoing oversight, we proceed to the project execution phase. Our team of experts diligently carries out the project activities, committing to the timelines set during project initiation. It is crucial for both sides to ensure that proposed timelines are met to avoid delays and setbacks.
Step 5: Closeout Meeting
As the project nears completion, we prepare for the closeout meeting. Any open topics are addressed during this meeting, and we share valuable lessons learned for both parties. This collaborative approach ensures that we continuously improve our processes and that you benefit from the insights gained during the project.
Need help with your qualification and validation projects?
At the QbD Group, we commit to excellence in qualification and validation projects. We hope this high-level overview of our project management process has provided you with valuable insights into how we approach these projects.
If you are seeking a partner for your next qualification and validation project, we invite you to reach out for an initial meeting to discuss this in more detail. Together, we can navigate the complexities of compliance and bring your facilities ready for production with confidence.
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