Reference Projects
Current projects (selection)
2024
- Project consulting and contract coordination for a new reprocessing unit of medical devices (CSSD)
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Coordination of a transfer project from initialization, production of the validation batches incl. packaging, support of the client during the entire registration process to the first commercial delivery (first-wave-launch)
- Clean room planning and planning of climate chambers including qualification
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Validation of the infrastructure for clean media, cleanrooms and monitoring
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Project management and management of the planning phase of the new construction of a Solida production facility
- Design clean room area for clinical reproductive medicine (building and technical equipment) including qualification
Completed projects (selection)
- Management of complaints and deviations, root cause analysis, implementing CAPA’s in a production of disinfection’s
- Engineering & planning for the integration of equipment into a new building: facility layout, hygiene design, material/personnel flows, negotiations, management of all specialist planners
- Multi-project management to increase production performance by reducing of transfer times (biotechnology)
- Agile project management in the context of CAPA implementation
- Consulting for the expansion of production capacities (overall project coordination, engineering, procurement and qualification)
- Project management during the design phase of site consolidation on client side (leading pharmaceutical manufacturer)
- Advice on efficient production processes and equipment and optimization of clean room processes (sterile tunnel/ isolator) incl. translation into process flow diagram
- Advice on modern production methods, GMP requirements, clean room and equipment concept
- Project management in the construction of a new QC laboratory (all project phases), including cost and schedule control
- Project management for the upgrade of an existing supply of pure media (production, storage, distribution) on the client side (leading pharmaceutical manufacturer)
- GMP compliance support to a manufacturer of special devices for sterile filling
- Preparation of all planning and tendering documents, including preparation of risk analysis for critical pure media
- Coordination of the technical and organizational measures for the production of certified mouth-nose protection masks
- Project management for a contract manufacturer upgrading its solid production
- Feasibility study for the implementation of a sterile production in an existing building (testing for material and personnel flow and hygiene zones, incl. supply technology for high purity media and air conditioning)
- Containment process consulting for the upgrade of the production of hormone products for a leading international manufacturer
- G+Q Lead and process consulting for the upgrade of a sterile filling line (planning and realization)
- Development of a concept for the parallel production of drugs and non-medications (process technology, operating and hygiene concept)
- Creation of an overall site concept for worldwide supply (incl. U.S.) of the entire product portfolio (identification of all necessary measures for a successful implementation)
- Feasibility study for the expansion of the production of a contract manufacturer in the area of hormone production (user requirements, room program, process flows, cost estimation)
