Process Characterization: Ready For The FDA?
Learn the Process Characterization basics, including if it’s a requirement or if optional, and more! Greg Sears, Ph.D, Global Director, Process Characterization, Head of Manufacturing Science and Technology, Pharma Services, Biologics at Thermo Fisher Scientific, focuses on:
- Why is Process characterization important
- What does “good” process characterization look like
- Impact of process characterization and process validation/PPQ campaigns
- Review available choices and the risks/rewards
- Learn how to speed up the process
