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Session 4: Continuous Manufacturing and ICH Q13
Session Chair(s)
Maria Guazzaroni Jacobs, PhD
Director, Quality Intelligence, Global Supply
Pfizer Inc, United States
Learning Objective :
Upon completion of this session, the participant should be able to:
- Understand the benefits and challenges of using continuous manufacturing
- Learn how industry and regulators are working together under ICH Q13 to harmonize the approach to CM
- Discuss with colleagues from both industry and regulatory agencies on lessons learned when applying CM
Speaker(s)
Speaker
Maria Guazzaroni Jacobs, PhD
Pfizer Inc, United States
Director, Quality Intelligence, Global Supply
Speaker
Manuel Osorio, PhD
FDA, United States
Senior Scientist for Emerging Technologies, OD, CBER
Speaker
Daniel Blackwood
Pfizer Inc, United States
Director, Pharm Science Technology and Innovation
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