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2020 ISPE Continuous Manufacturing Virtual Workshop


Analytics Considerations for Continuous Manufacturing


Jun 24, 2020 12:00am ‐ Sep 11, 2020 6:08am

Description

Analytics Considerations for Continuous Manufacturing

Analytics Considerations for Continuous Manufacturing This session will be a series of presentations related to analytics and release assays critical to successful implementation of CM. The session will include perspectives on emerging approaches for assessment of quality attributes, on release testing, and on the importance of process control and PAT.

  • Quality Considerations for the Multi-Attribute Method (MAM)
    Sarah Rogstad, Staff Fellow, Chemist
    FDA
  • Modern Microbiological Monitoring of Continuous Processing
    Cheryl Essex, Head of Microbiological Control for Biologic Drugs
    Sanofi
  • Integrating Analysis with Process Control for the Continuous Bioprocessing: Extending the Lifecycle Concept to Process Analytical Technologies
    Jose C. Menezes, PhD, President and CEO
    4Tune Engineering Ltd

Moderator(s):

  • Jeffery Odum, CPIP, Head of Design, Technology & Standards, Biologics Engineering, Sanofi

Speaker(s):

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