Medical Devices

Manufacturing

  • Development of strategy and approach to streamline manufacturing efforts
  • Assistance with Facility design
  • Master planning, scheduling and tracking of manufacturing start-up efforts
  • Composing and reviewing manufacturing documents, including:
    • Development/Pilot scale characterization protocols and reports
    • SOPs, batch records, and related GMP documents
    • Process Flowcharts
  • Troubleshooting differences in process performance/product qualities at different scales
  • Risk assessments of manufacturing methods
  • Tolerance/Specification development and parameter classification
  • Technical investigation of deviations and out-of-specification results
  • Hands-on assistance during manufacturing start-up activities (person in plant)
  • Process and related equipment validation, including utilities, computer systems and other automated systems
  • Writing and review of documents for global regulatory submissions
  • Long-term planning and process feasibility (Project Management)