Eight years after the FDA issued its guidance of process validation, some still ask the question “Is process characterization optional anymore?” 

This webinar will cover the basics of process characterization, whether it is optional or not, and what “good” process characterization really looks like. 

Since different approaches to process characterization can be taken, the webinar closely examines the risks and rewards of these different approaches.  The webinar also presents several case studies that highlight the role process characterization can play in preparing for successful PPQ campaigns and approvals.

Featured Speaker

Greg Sears, Ph.D

Global Director, Process Validation
Head of Manufacturing Science and Technology
Pharma Services, Biologics
Thermo Fisher 

Greg has been devoted to biologics manufacturing for 23 years, has written multiple industry articles related to process validation applicable to both single use technologies and standard processing techniques. He was an industry contributor to the current revision of EMA Annex 15, and has been a contributor in BPOG’s working group related to data capture and data trending.


Register now for this webinar