Joint CVG/Therapeutic
Products Directorate (TPD)
2006 INTERNATIONAL CONVENTION AND EXHIBITIONS
"Challenges to the Pharmaceutical
Industry and the Impact on the Laboratory
"
October 5-6, 2006 (Toronto,
Ontario, Canada)
Double Tree International Plaza Hotel, 655 Dixon Road, Toronto
Tel: 416-244-1711, www.internationalplaza.com
This convention will be conducted in English.
Program
|
 |
October 5,
2006 - Plenary
Session
|
|
| Introduction and Start of Programme |
Chung Chow Chan, Ph.D. |
8:40AM - 8:45AM |
|
| Opening Remarks |
Herman Lam, Ph.D.
|
8:45AM - 8:50PM |
|
Key Note Address:
|
David Mayers
Director QA
Purdue Pharma
|
8:50AM - 9:35AM |
|
|
Challenges to identify
counterfeit drugs using the latest analytical technology: An
overview of the “critical path” and the application novel
technologies
|
Patrick Faustino,
Ph.D.FDA |
9:35AM - 10:20AM |
|
| Morning Break |
|
10:20AM - 10:50AM |
|
| Quantifying
impurities – Strategy for impurity evaluation
|
Tom Barker,HPFBI,
Health
Canada
|
10:50AM - 11:25AM |
|
|
The
New USP <1226> Verification of Compendial Procedures
|
Horacio Pappa, Ph.D.,USP
|
11:25AM - 12:00PM |
|
| Lunch Break |
|
12:00PM - 2:00PM |
|
| Formulation
Development in the 21st century |
Satish Asotra, Ph.D.,
Taro Pharm
|
2:00PM - 2:35PM |
|
| Extractables
and Leachables |
Anthony Grilli, SGS
Life Sciences
|
2:35PM - 3:10PM |
|
| Break |
|
3:10PM - 3:40PM |
|
| How to Respond
to Regulatory Questions |
James Vesper,
Learning Plus
|
3:40PM - 4:15PM |
|
|
Pharmaceutical Process
Analysis: Implementing FT-NIR into a PAT Control Based
Architecture
|
David Edwards, Thermo
Electron
|
4:15PM - 4:50PM |
|
| Wrap Up for the Day and Door Prizes |
Elaine Vanderberg Ph.D.
|
4:50PM - 5:15PM |
|
| |
| October 6,
2006: Discussion
Group Sessions |
|
| Breakfast |
|
8:30AM - 9:00AM |
|
| Round Table Parallel Discussion Sessions |
|
9:00AM - 12:15PM |
|
| |
Round Table Parallel Discussion
Sessions (9:00AM-12:15PM)
Session 1: Pharmacopoeial
Chair: Dean Callaghan,
AstraZeneca |
|
|
| Q4B |
|
|
| Rapid
Micro Testing |
Tim Farmer, CRL |
|
| Harmonization
of Excipient Momographs |
Janeen Skutnik,
Pfizer |
|
| Strategies
for Controlling Impurities |
Gary Condran,
Therapeutic Products Directorate |
|
Session 2: Pharmaceutical
Analysis: HPLC Separation and Dissolution
Chair: Malcolm
Angod, Eli
Lilly Canada Inc
|
|
| Method
Transfer |
Pauline
McGregor, Ph.D., PMcG Consulting |
|
| Phase
Appropriate Method Validation |
Geoff Carr,
Patheon
Canada
TBA |
|
| The
Combination of Raman Micro- and Macro-Spectroscopy for
MultiPoint
Sampling
and Imaging, |
Mark Kemper,
Kaiser Optical Systems |
|
| The
Use of Water Activity in the Pharmaceutical |
Neil Pearson,
Eli Lilly Canada Inc |
|
|
Session 3: Process Analytical
Technology & Equipment Calibration
Chair: David
Mayers,
Purdue Pharma Canada |
|
| How
to Set Acceptance Criteria for PAT – Business Application |
Patrick Okoye,
Mathis InstrumentTBA |
|
| Design
Space for PAT |
Paul Scott,
Ph.D., AstraZeneca |
|
| On-line
Particle Size PAT using FBRM |
Terry Redmon,
Autochem |
|
| Innovative
Approaches to Dissolution Calibration |
YC Lee, Ph.D.,
PharmEng Innovations |
|
Session 4: Process Validation
Chair:
Jerry Holatko, PharmEng Technology Inc. |
|
| Process
Validation Update |
Jerry Holatko,
PharmEng Technology Inc. |
|
| Cleaning
Validation for Biotech Process or Process Validation for
Biological Products |
Kant Ragbeer,
Genpharm Inc |
|
| Statistical
Process Control in Process Validation |
John McCluskey ,
PharmEng Technology Inc. |
|
| Technology
Transfer Challenges for a Successful Process Validation |
Le Trong Vu,
Purdue Pharma |
|
