GMP Training "Sterilization validation in aseptic pharmaceutical production" (2 days)

CONTENT DAY 1

  • Welcome and Introduction
  • Sterilization types and sterilization validation
  • Coffee Break
  • Sterilization Validation – practical approaches
  • Lunch Break
  • Workshop project planning and risk analysis
  • Presentation and discussion of Workshop results
  • Coffee Break
  • Special Topics - Sterilization validation
  • Final Discussion Day 1

CONTENT DAY 2

  • Physical measurement and bioindicators for sterilization validation (measurement points and optimization techniques)
  • Workshop measuring points and optimization by means of bracketing and "worst-case" approaches
  • Coffee Break
  • Presentation and discussion of Workshop results
  • Lunch Break
  • Special Topics - depyrogenation
  • Coffee Break
  • Special Topics - sanitisation
  • Final Discussiony

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