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Regulatory Perspectives on Biopharmaceutical Quality from the FDA

International Society for Pharmaceutical Engineering

Thursday, April 24, 2014 from 3:00 PM to 6:00 PM (EDT)

Durham, NC

Regulatory Perspectives on Biopharmaceutical Quality from th...

Ticket Information

Ticket Type Sales End Price Fee Quantity
ISPE-CaSA Member Ended $40.00 $0.00
ISPE-CaSA Non-Members Ended $60.00 $0.00
ISPE-CaSA Student/YP Members Ended $25.00 $0.00
Sponsor Ended $300.00 $0.00

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Event Details

Please join us for this dynamic Educational Event!

Dr. Steven Kozlowski, Head of the Office of Biotechnology at the FDA, will be live via video conference from Philadelphia to RTP presenting on the Role of Modern Analytics in the Development of Control Strategies for Complex Biotechnology Derived Products. 

The presentation will cover Quality (structural and functional characterization), Assuring Quality (quality by design, control strategy, and quality systems), and looking to the future in of controls in this area.  Although this presentation is specific to biopharmaceutical quality, parallels can be made to other areas within the pharmaceutical industry.  

You don't want to miss this information!

Presentation: 3:00-5:00pm 

Reception: 5:00-6:00pm

Light Hor D'oeuvres and Drinks will be served 

 

Have questions about Regulatory Perspectives on Biopharmaceutical Quality from the FDA? Contact International Society for Pharmaceutical Engineering

When & Where



North Carolina Biotechnology Center
15 T W Alexander Dr
Research Triangle Park
Durham, NC 27703

Thursday, April 24, 2014 from 3:00 PM to 6:00 PM (EDT)


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Organizer

International Society for Pharmaceutical Engineering

ISPE Carolina-South Atlantic Chapter is a not-for-profit volunteer society of technical professionals who apply their practical knowledge in the regulated pharmaceutical and medical device manufacturing industries. The Chapter is committed to the advancement of the educational and technical efficiency of its nearly 1300 members through forums for the exchange of ideas and practical experience.

ISPE Carolina-South Atlantic is one of ISPE's more than 30 North American Chapters and worldwide Affiliates. ISPE Carolina-South Atlantic is one of the Society's largest and most active chapters, and was awarded ISPE's prestigious Chapter Excellence Award in 1997, 1998 and 2000, and Chapter of the Year in 2008, 2007, 2006, 2003, 2001, 2000, 1998 & 1997.

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