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CURRENT
CONFERENCE
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Joint
CVG/Therapeutic Products Directorate (TPD)
2007 INTERNATIONAL CONVENTION AND EXHIBITIONS
"Quality by
Design"
October 4-5,
2007 (Toronto,
Ontario, Canada)
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| Introduction and Start of Programme |
Chung Chow Chan, Ph.D. |
8:40AM - 8:45AM |
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| Opening Remarks |
Herman Lam, Ph.D.
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8:45AM - 8:50PM |
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Key Note Address:
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Sultan Ghani
Director, BPS,
TPD
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8:50AM - 9:35AM |
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Scientific and Regulatory challenges in
Quality by Design (QbD) submissions |
Krishnan
Tirunellai, Ph. D., TPD |
9:35AM - 10:20AM |
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| Morning Break |
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10:20AM - 10:50AM |
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| Question
Based Review ¡V Implementation of Quality by Design
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Lawrence
Yu, Ph.D. FDA
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10:50AM - 11:25AM |
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USP
Perspectives and Future Directions
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Todd Cecil, Ph.D.
USP
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11:25AM - 12:00PM |
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| Lunch Break |
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12:00PM - 2:00PM |
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| Statistical
Design of Experiment |
Andy Tallevi,
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2:00PM - 2:35PM |
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| Application
of quality by design - an industry perspective |
Louis Yu, Pereira
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2:35PM - 3:10PM |
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| Break |
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3:10PM - 3:40PM |
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| NIR
Applications in PAT |
Hui Li, Ph.D., Bruker
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3:40PM - 4:15PM |
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Follow On Biologics
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Michelle Zheng, Ph.D, Hospira Inc
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4:15PM - 4:50PM |
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| Wrap Up for the Day and Door Prizes |
Elaine Vanderberg Ph.D.
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4:50PM - 5:15PM |
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| October
5, 2007: Discussion
Group Sessions |
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| Breakfast |
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8:30AM - 9:00AM |
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| Round Table Parallel Discussion Sessions |
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9:00AM - 12:15PM |
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Round
Table Parallel Discussion Sessions (9:00AM-12:15PM)
Session
1: Instrument Qualification and
Pharmaceutical
Analysis
Chair:
David Mayers, Purdue Pharma (for
presentation 1 and 2)
Chair: Malcolm Angod, Eli Lilly Canada
(for presentation 3 and 4)
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| Surmounting
sampling Challenges in Handheld Spectroscopy :Technology and
Operational Considerations - Robert Brush, Ahura Scientific Inc. |
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| On
line Particle Size Analyzer - Stefan Steigerwald, Sympatec |
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| Break |
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| Dissolution
Method development for Innovative Dosage Forms - Eric Beyssac ¡V
University Clermont-Ferrand1 - France |
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| Two
new Orbitraps for Small Molecule Applications - Brenda S. Kesler,
Ph.D., Thermo Fisher Scientific |
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Session 2: Pharmaceutical
Analysis: Quality for Generic Products
Chair:
Krishnan Tirunellai, Ph.D., TPD Health
Canada
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| Q&A
on Question Based Review - Lawrence Yu, FDA |
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| Quality
of generic products ¡V TPD perspectives - Anita Di Franco, TPD |
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| Break |
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| QBD
for generic products ¡V industry perspectives - Louis Yu, Pereira |
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| Product
Development in the Generic Industry ¡V The Challenges and the
Thrills ¡V David Brown, Novopharm |
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Session 3: Process Validation
Chair:
Jerry Holatko, PharmEng Technology Inc.
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Parenteral
Drug Products Process Validation ¡V
Socrates Nelson, PharmEng Technology Inc. |
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Manufacturing
equipment validation ¡V Rick Montgomery,
Purdue Pharma |
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Break |
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Using
a PQRI Approach in Process Validation ¡V
Darlene McKay, McNeil |
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Process
validation - a case study |
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Sultan Ghani, Therapeutic Products Directorate
Krishnan
Tirunellai, Ph. D., TPD
YC Lee, Ph.D. PharmaEng Innovations
Chung Chow Chan, Ph.D., AzoPharma
Herman Lam, Ph.D., GlaxoSmithKline Canada Inc.
Xue-Ming Zhang, Ph.D., Apotex
Katherine Yang, Ph.D., GlaxoSmithKline Canada Inc.
Elaine Vandenberg, Ph.D., GlaxoSmithKline Canada Inc.
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Herman Lam, Ph.D.
Chung
Chow Chan, Ph.D.
YC Lee, Ph.D.
Xue-Ming Zhang, Ph.D.
Katherine Yang, Ph.D.
David Mayers,
Gabriel Lam
Wei Garofolo
William Ng
Tony Cheung
Yu-Hong Tse, Ph.D.
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