Project Details
Context
Our Client is an international manufacturer of Class 2B neuro-life science products. The challenge was to project manage the transfer of a product and process licenced from a US-based competitor, initially to their UK plant, and ultimately to Ireland. This localisation project involved many risks and high complexity, requiring tight management and control. Achievement of the scheduled handover date was critical. Project management expertise was an essential prerequisite, coupled with experience of process transfer, validation and ramp-up in highly-regulated environments. Project scope included re-layout of the manufacturing site in Ireland to accommodate the new process.
- Clients: Manufacturer of Class 2B Neuro-Life Science Products
- Solution:Extensive Project Management, Planning and Communication to establish new manufacturing plant in Ireland
- Date:2018
- Sector:Medicine
Objectives and Scope
- Set up a new manufacturing site in Ireland.
- Transfer, install, commission and validate new processes.
- Set up new processes in the UK.
- Establish device production by agreed date.
Tecknic's Role
- Project review and development.
- Planning and team communication using, international conferencing, MS Project.
- Management of cross-functional project teams in UK & Ireland.
- International coordination of activities between US Multinational Companies.
- Technical support.
- Complex Project Management.

Achievements
- New manufacturing plant set up in Ireland with supporting facilities.
- Capable resources to manage and support the manufacturing process.
- Product and processes transferred in part to the UK and Ireland.
- Processes validated successfully.
- Supply chain set up and engaged.
- ISO 13485 design management approval & FDA GMP approvals (GAMP4) obtained.
- Managed CE Marking and UL registration for the product.
- On time commencement of production.
- Plant management support in place.