Development of a Validation Strategy / Management of Qualification and Validation Activities

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Development of a Validation Strategy / Management of Validation Activities

Medical Device industry


Études de cas CaduceumAchievements

  • Development of a validation strategy
  • Priorisation of qualification and validation activities
  • Site Validation Master Plan
  • Planning of qualification and validation activities
  • Update of qualification and validation procedure
  • Special process validation

 

Études de cas CaduceumGovernance & Project Management

  • Daily stand up meeting
  • Blocking point management
  • Technical troubleshooting
  • Bi-monthly steering committee

 

Norms  Iso 13485 – Iso 11607
Key Skills Qualification Validation
Type of Commitment Day to Day Basis
CaduCeum Team 2 consultants

Management by 1 SME

Duration 4 months