Worst case selection for aseptic filling validation (APS/MFT)

Worst case selection for aseptic filling validation (APS/MFT)

Details

  • Start date: 29 November 2022
  • Start time: 14:00 (Kyiv)
  • Finish date: 29 November 2022
  • Finish time: 16:00 (Kyiv)
  • Duration: 2 hours
  • Break: no
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • 1. GMP requirements for "worst case" planning for aseptic filling validation.

    2. Development of a strategy for conducting validation of aseptic filling according to the “worst case” scenario.

    3. Planning microbiological monitoring for aseptic filling validation.

    4. Risk-based approach to evaluating the results of aseptic filling validation.

    5. Assess the need for revalidation of aseptic filling.

     

    Bonus: A self-test checklist for evaluating the factors that make up the "worst case" for aseptic filling.