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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
Continuous manufacturing (CM) is used to manufacture, produce, or process materials without interruption. There are several advantages of CM, such as being an integrated processing with fewer steps, no manual handling, shorter processing times, and increased efficiency. They are more flexible operations that use smaller equipment and facilities. They allow for online monitoring and controls which result in increased and consistent product quality. During this session, an agency representative in the ICH Q13 team will give an update on the ICH guide on CM and an industry representative will discuss industry experience with CM and present case studies. The two presentations will be followed by a Q&A panel.
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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