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IFPAC2014article4pgAPR1b6c.qxp 12/10/2013 12:46 PM Page 4 Friday, January 24, 2014 - AM


Analytical QbD Implementation of QbD for Analytical Methods Chairs: Sonja Sekulic and John Kauffman, FDA


Special ISPE Session Next Stage of QbD Implementation Chairs: Stephen Tyler and Dora Kourti


BioPharma/BioProcessing Bio-Tech - III: Bio-Processing/Bio- Transformations Chairs: Antonio Moreira and John Higgins


QbD - Regulatory QbD - III: Regulatory Discussion Session...Topic: Implementation of Question based Review (QbR) for Generic & Brand Industry Chairs: Lawrence Yu, FDA and Ramesh Sood, FDA


BioPharma/BioProcessing Process Control for


Biotechnology/Pharmaceutical Chairs: Cenk Undey and Jose C. Menezes


Exhibition Schedule:


Join your fellow exhibitors at IFPAC-14: •ABB Analytical Measurement • Advantest Corporation • American Pharmaceutical Review • Applied Instrument Technologies (AIT) • art photonics GmbH • ASTM • Bayer Technology Services GmbH • Brimrose Corporation of America • Bruker Biospin • Bruker Optics • BUCHI Corporation • Canty • CEM Corporation • CPAC, Center for Process Analysis and Control


• CPACT • DA-SOL GmbH • DIR Technologies • Dispersion Technologies, Inc.


Wednesday, January 22nd ..........2:00 - 7:00 PM Grand Opening..................2:00 PM


Thursday, January 23rd ..............10:00-4:00 PM Friday, January 24th ....................9:00-12:00 Noon


• Duquesne University • European Pharmaceutical Review • Extrel CMS • Falcon Analytical/Chrom Perfect • Flownamics Analytical Instruments • Food Processing • Freeman Technology, Inc. • 4TUNE Engineering, Ltd. • GEA Pharma Systems • H2Scan Corporation • INDATECH SAS • InnovaPrep • Instant BioScan, LLC • Intellicentic • IFPAC • ISPE • JDSU • Kaiser Optical Systems • New Food • Nova Biomedical


• Pharmaceutical Manufacturing • PharmaQbD.com • Polytec, Inc. • Rigaku Raman Technologies • Rimbach • Sartorius Stedim Biotech • Sentronic GmbH • Siemens Industry, Inc. • Tec5USA • Thermo Fisher Scientific • Thermo Scientific • Umetrics • VTT Technical Research Centre of Finland


• Yokogawa Electric Corporation


Don’t miss this opportunity. Full exhibition services will be provided during the three day exhibit. Companies interest- ed in exhibiting are invited to contact exhibition manage- ment as soon as possible.


Email: info@ifpacnet.org Tel: 847-543-6800.


QbD - Quality by Design QbD in CMO/CRO Chair: Manoharan Ramasamy


Generic Industry Symposium QbD and PAT in the Generic Industry Chairs: Daniel Peng, FDA and Inna Ben-Anat


Process Control & Monitoring PAT Links to Post-Approval Manufacturing (PV and CPV) Chairs: Ranjit Deshmukh, Tara Gooen, FDA and Vibhakar Shah, FDA


Friday, January 24, 2014 - PM


Lifecycle Management Lifecycle Control and QA Chairs: Rick Friedman, FDA and Tom Garcia


Continuous Manufacturing Continuous Manufacturing - II Chair: Fernando Muzzio


Plus... Fundamental University Research &Its Industrial Applications, and MASS Spectroscopy/Process Spectroscopy


Additional presentations to follow... see our website for continuous updates: www.ifpacpat.org


Plus... Chemometrics (COPA) - II and Particle Characterization


IFPAC Posters Located in the Exhibit Hall Chairs: Antonio Moreira and Walter Henslee


Additional presentations to follow... see our website for continuous updates: www.ifpacpat.org


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| November/December 2013


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