Qualification of 7 Fabrication Platforms -OTC Products

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Qualification of 7 Fabrication Platforms -OTC Products

Cosmetics industry


Études de cas CaduceumAchievements

  • 7 Validation Master Plan
  • 7 Risk analysis
  • Installation qualification with déviations and CAPA Management
  • Operational Qualification protocols and planification of OQ tests
  • Performance Qualification protocols

 

Études de cas CaduceumGovernance & Project Management

  • Daily stand up meeting
  • Blocking point management
  • Technical troubleshooting
  • Review of quality documents producted
  • Weekly meeting with the client
  • Management of the Weekly steering committee

 

Norms  GMP Annex 11 and 15 – 21 CFR parts 11, 210 and 211
Key Skills Qualification CSV
Type of Commitment Statement of Work
CaduCeum Team 2 teams of 2 consultants

Management by 1 SME

Duration 4 months