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IFPAC/INDUNIV PAT Summer Summit
June 10 - 12, 2008
Condado Plaza Hotel
San Juan, Puerto Rico
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PRELIMINARY PROGRAM
June 10, 2008
Pre-Conference: Presentations and Dinner Activity
- The Essence of PAT: Leveraging the Core Technology of Process Analytics
R.J. Romañach UPR-M and Vicente Rosado, Wyeth Pharmaceutical Products
June 11, 2008
Day 1: Advances in PAT - Understanding & Monitoring Processes
Morning Session
- Welcome and Introduction
R.J. Romañach, UPRM
- QbD, PAT, and the Agencies Perspective
Christine Moore, FDA, OPS, ONDQA, Silver Spring, MD
- PAT/QbD - Improving Pharma Process Understanding
Stephen M. Tyler, Abbott, N. Chicago, IL, USA
Lunch
Afternoon Session
- BMS-Applications of Chemical Imaging
Gary McGeorge, BMS
- Progress in Puerto Rico: PAT & Quality by Design
Overview of PAT Progress at Wyeth
Carlos Conde, Wyeth
- Overview of PAT Progress Pfizer
Jose Montenegro, Pfizer
- Quality by Design -Experience.
Eduardo Maldonado, Merck
Reception
June 12, 2008
Day 2: Design Space and Control
Morning Session
- QbD, PAT, and CMC Pilot Programs
Rebeca Rodriguez, FDA
- Using Raman Spectroscopy to Design a Protein Crystallization Process
R.J. Romañach & J.L. Rios, UPR-M
- Connecting Analyzers to the Process
Manuel Hormaza, IBS Caribe, San Juan, PR
- Quality by Design Submissions to FDA
Wyeth Representative - Carlos Conde et. al.
- Pharmaceutical Process Understanding Talk - Bio Process.
Author TBC
Lunch
Afternoon Session
- Analytical Instruments that Integrate into PAT Systems
Ivelisse Colon-Rivera, Pfizer, Groton, CT
- Fundamentals of Extrusion Processes
Authors TBC
- Successful Applications of NIR Spectroscopy at Menarini Labs, Spain
Dr. Manel Alcala
- Multivariate analysis based on Design Space
Authors TBC
- Data Management system based on control strategy
ABB et al.
Reception