A-27. GMP Compliance issues for Aseptic Processing

  • Review new and controversial revised/updated FDA requirements and interpretations for aseptic processing; examples:
    • Facilities design
    • Raw material controls
    • Production controls
    • Equipment control and maintenance
    • Environmental monitoring
    • Sterilization validation
    • Media fill validation
    • Isolator and RABS
  • Recent major FDA warning letter citations
Level: A | Approx. Time: 60 min.