IFPAC2014article4pgAPR1b6c.qxp 12/10/2013 12:46 PM Page 3
Schedule of Events:
Continuous Manufacturing Continuous Manufacturing - I Chairs: Vibhakar Shah, FDA and Dora Kourti
BioPharma/BioProcessing Rapid Micro Methods (RMM) for Manufacturing Roles Chairs: Jeff Weber and Bryan Riley, FDA
Lifecycle Management Risk Management Over Product Life Cycle - I Chairs: G. K. Raju & Rick Freeman, FDA
QbD - Quality by Design QbD - I: Implementation of QbD for Small Molecules Chairs: Lorenz Liesum and Sarah Pope Miksinki, ONDQA/FDA
BioPharma/BioProcessing Bio-Tech - I: Real Time Monitoring of Bio-Reactors and Bio-Processing Chairs: Kurt Brorson and Michael Tarlov
Lifecycle Management Risk Management Over Product Life Cycle - II Chairs: G. K. Raju & Daniel Peng, FDA
QbD - Quality by Design QbD - II: Implementation of QbD for Complex Dosage Forms Chairs: Sharmista Chatterjee, FDA, and Dora Kourti
BioPharma/BioProcessing BioTech - II: MSAT in Biologics Manufacturing Chairs: Ranjit R. Deshmukh and Jose C. Menezes
Lifecycle Management Lifecycle Management of Analyzer and Method Robustness Chairs: Gert Thurau and Martin Warman
www.ifpacpat.org Wednesday, January 22, 2014 - PM
International QbD Experience with QbD Submissions Internationally: Future Steps with QbD & PAT Chairs: Evdokia Korakianiti, EMA and Christine Moore, FDA
This half day session for IFPAC-2014 will focus on European, Japan and USA Agency perspectives and the lessons learned. It will include what we need to see as regulators and the concerns for imple- menting and the submissions. Formal speaker presentations will be followed by an in-depth panel discussion.
Plus... Advanced Separations and Process Raman
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
Thursday, January 23, 2014 - AM
Special IQ Session Multivariate Model Validation in a Quality Environment Chairs: Doug Both and George L. Reid
Process Control & Monitoring Process Monitoring & Control - I: PAT Implementation for Drug Product Development & Manufacturing Chairs: Tim Stevens and Gawayne Mahboubian-Jones
Plus... Chemometrics (COPA) - I and Advanced Instruments Concepts Customization of Instrumentation
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
Thursday, January 23, 2014 - PM Generic/Brand Industry
Applications Using Process Capability to Ensure Pharmaceutical product Quality - Industry and Regulatory Perspective (Brand and Generics) Chairs: Lawrence Yu, FDA and Daniel Peng, FDA
Process Control & Monitoring Process Monitoring & Control - II: Process Automation/Intelligence Based Manufacturing (IbM) Chairs: Mojgan Moshgbar, Ke Hong and Tahseen Mirza, FDA
Plus... NeSSI and Imaging 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
IFPAC
253 Commerce Dr. Suite 103 Grayslake, IL 60030 USA Tel: 847-543-6800 Fax: 847-548-1811
info@ifpacnet.org Copyright 2013 IFPAC, Grayslake, IL 60030
www.americanpharmaceuticalreview.com |
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