Part 3 — The Role of Project Management to Ensure a Smooth Technology Transfer
Posted by Dara Caratao
Jun 2, 2016 11:17:43 AM
Technology Transfer: Want To Get It Right?
[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 3 of an in-depth, multi-part series on tech transfer. Visit our blog page to view additional segments.]
When a prospective client asks, “What can we do on our end to ensure a smooth technology transfer to your contract manufacturing facility?” we breathe a sigh of relief. Ultimately, a contract manufacturing facility will need to rely on key insight from the client for a successful technology transfer.
From a project management standpoint, there are two main items manufacturers require from the client at the very beginning of the project:
- Clearly defined project scope requirements
- A complete technology transfer documentation package
A defined project scope eliminates guesswork. One way to achieve this is with a comprehensive request for quotation (RFQ) from the sponsor; another is a meeting to clearly define the technical scope. It is important to finalize the project parameters in the agreement negotiated between the sponsor and CMO. This agreement serves as the project scope that is discussed at the project kickoff meeting, which is when a clear path for execution needs to be defined. Unexpected changes in scope or missing information could impact and delay the timeline for the technology transfer. By identifying all the required activities in advance, inaccuracies in the quote are minimized and the job of preparing master documents is greatly simplified.
Create a Blueprint for the Project
Assembling the project team for a cross-functional kickoff will help identify the tasks required as well as critical path items and potential roadblocks. Working together to generate the project timeline with agreed-upon milestones helps secure buy-in from all those concerned and ultimately provides the blueprint for the project. As the project is executed, regular project team meetings and open communication between team members will be essential for a smooth transfer.
Once a client approves a tech transfer quotation, the project team members instantly support the project — and their project manager — by submitting a purchase order for deliverables and by providing a technical documentation package. With those in hand, the project manager can:
- Schedule a kickoff meeting with representation from each department to review the quote, background, purpose and project scope.
During this internal kickoff meeting, the project scope is reviewed with all internal team members. Expectations are discussed with each representative weighing in on their particular area of expertise — materials, analytical testing, production, packaging, validation, quality assurance. It is critical that proper resourcing in each of these areas is contemplated and allocated at this point to ensure project scope activities are met according to the sponsor timelines and requirements.
- Work with the group to brainstorm and identify tasks and assign resources and due dates based on project deliverables and tech transfer milestones.
To ensure that proper project resourcing is identified and allocated, it is often necessary to brainstorm how each department may identify the necessary resources required at the right time to meet project timelines. Because resources are not unlimited and may not always be available when they are needed, the group must rely on teamwork, accountability and leadership to develop creative solutions. As the team host responsible for the overall project plan, the project manager can be the catalyst to elevate the team’s thinking to generate these creative solutions. With management experience over many projects, project managers can facilitate putting many different ideas together to create these solutions.
- Identify requirements, risks, constraints and action items with each responsible party.
A good project manager will capture the interaction during internal and external project meetings; help identify and document project requirements, risks and constraints; and track action items for the project team on an on-going basis. This is important so the project team can stay focused on what each member needs so that the project is completed on time and on budget.
- Publish kickoff meeting minutes, with the agreed upon project timeline and action items, for both the internal team and the client.
Once an internal project plan is developed by the receiving site, that plan must be shared with the transferring site or sponsor so that consensus can be gained by both parties — usually during a formal kickoff meeting with representatives from both organizations. Any adjustments to the project plan must be agreed on by both parties, and a final timeline must be generated. These adjustments and agreements to the project plan should be documented thoroughly in kickoff meeting minutes. Publishing of these meeting minutes will ensure there is no misunderstanding of the action items or detailed timelines that all have agreed to. The captured meeting minutes are the starting point to track all future project review meetings and outcomes from the work required in the project scope.
- Monitor project tasks through a combination of one-on-one follow-ups and regular project meetings; provide a status update of the project progress.
The project manager must be a catalyst to organize and lead the entire project team. Furthermore, the project manager must be adept at building relationships with all team members so that the project plan remains on track and that constraints, delays and completion of action items are documented and communicated to the rest of the team. These relationships can develop either through one-on-one interactions or during project team meetings. Regular communication and follow-up are required so that timely updates to the project plan can be captured and documented and project progress can be communicated and discussed.
The sponsor is the main provider of the project expectations, and the project manager, with the team, is the executor of those expectations. With the two combined in a strong and supportive partnership, a technology transfer is bound to progress in the right direction.
Next Time: Part 4 — How are Analytical Methods Exchanged in a Technology Transfer?
Dara is the Project Director in the Business Development Department at WellSpring, and has over fifteen years of pharmaceutical industry experience. After graduating from the University of Toronto and acquiring her Honours BSc. in Toxicology, Dara worked at Patheon, holding positions in Account/Business management, Client Services, and Project management. In 2008, Dara joined the WellSpring team, and is responsible for overseeing in-house transfer and execution of projects for clients of WellSpring Pharma Services.
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