Medical Devices

Technology Transfer and Validation

  • Development of strategy and approach to streamline scale-up efforts
  • Master planning, scheduling and tracking of validation efforts
  • Project team management
  • Composing and reviewing scale-up documents, including:
    • Pilot scale characterization protocols and reports
    • Small scale model protocols and reports
    • SOPs, batch records, and related GMP documents
    • Process flowcharts
    • Commissioning protocols
    • Validation Master Plan, protocols, and reports
  • Development of dimensionless correlations and scaling factors
  • Troubleshooting differences in process performance at different scales
  • Risk assessments of process methods, process additives, and leachables/extractables
  • Gap analysis
  • CMC section writing and review for global regulatory submissions
  • Specification development and parameter classification
  • Technical investigation of deviations and out-of-specification results
  • Hands-on assistance during engineering runs, commissioning, validation, and other process implementation activities (person in plant)