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Informa

Margit Holzer, Ph.D.
Scientific Director at Ulysse Consult S.a.r.L

Agenda Sessions

  • How to Address Quality Requirements for Continuous and Intensified Bioprocesses

    11:00
  • Course Leaders Opening Remarks

    08:55
  • Introduction to ICH Guidance’s and Revised Validation EMA and FDA Guidance’s

    09:00
  • Traditional and Enhanced (Quality by Design) Pharmaceutical Development

    09:30
  • Risk Management Methodologies and Practical Considerations

    10:00
  • Stages in Process Development

    11:15
  • Control Strategy Development

    13:45
  • Process Performance Qualification and Continued Process Verification

    15:00
  • LIVE: Conclusions and Feedback

    15:30

Speakers at this event