Description

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.

Moderator(s):

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

Speaker(s):

• Sarah Rogstad, PhD, Staff Fellow, Chemist, Office of Testing & Research, CDER/FDA
• Cheryl Essex, Head of Microbiological Control for Biologic Drugs, Sanofi
• José Menezes, PhD, CEO, 4Tune Engineering Ltd