Process Validation – Dry Forms

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Process Validation - Dry Forms

Pharmaceutical industry


Études de cas CaduceumAchievements

  • Process risk analysis with identification of critical process parameters (CPP) and critical quality attributes (CQA)
  • Development of the process validation strategy
  • Verification of prerequisites for process validation
  • Process validation protocol

 

Études de cas CaduceumGovernance & Project Management

  • Daily stand up meeting
  • Blocking point management
  • Technical troubleshooting
  • Weekly meeting with the client

 

Norms  GMP Annex 15 – 21 CFR part 210 et 211 – ICH Q9
Key Skills Procedure Validation – Risk Analysis
Type of Commitment Day to Day Basis
CaduCeum Team  1 consultant

Management by 1 SME

Duration 2 months