Introduction and Opening Greetings

PAT Goals & Summary of Trends; A Perspective - Challenges and Process for Integrating PAT Tools.
David Radspinner, Thermo Electron, Madison, WI

Refreshment Break

PAT Update - PAT Comparability Protocols.
Rebecca Rodriguez, FDA, San Juan, Puerto Rico

Compatibility Protocols: A Case Study
John Dougherty, Eli Lilly, Indianapolis, IN

Innovation - New Technology Oxygen Headspace Analyzer
Nancy Rodriguez, Wyeth, Carolina, PR

Lunch

Knowledge Management and Continuous Improvement A Practical Case on a Strategy Towards Increased Process Knowledge and Continuous Improvement:Challenges and Experiences
Erik Prins, Siemens A&D, CC Pharma, Antwerp, Belgium

Risk Management: An Industry Perspective (TBA)
Zena Kaufman (TBC), Abbott Laboratory, N. Chicago, IL

Case Studies Reviews - 3 groups
Introduction to Case Studies (with ProActive Involvement) defining the impact of PAT on Pharmaceutical/BioPharmaceutical Manufacturing

Discussion Leaders (Case Study Participants Include)
Rebecca Rodrigues, FDA, Rebecca Parrilla, FDA, Manolo L. Hormaza, IBS Caribe, Rodolfo J. Romanach, UPRM, Ajaz Hussain, Sandoz, and David Gonzalez, UPRM, Industrial Engineering

Report on Discussions
Finalize

Meet to summarize

Network Reception

Introduction and Opening Remarks

PAT and Pharmaceutical Manufacturing: A Look at the Progress (TBA) - Perspective by the former Deputy Director, OPS, CDER,FDA
Ajaz Hussain, Ph.D., Sandoz, Princeton, NJ

Refreshment Break

New Applications of Raman Spectroscopy for Drug Content Uniformity, Coating Variability Analysis and Freeze Drying Monitoring
Saly Romero-Torres, Purdue. University, W. Lafayette, IN

Opportunities for Controlling Crystallization
Nair Rodriguez Hornedo, Univ. of Michigan, Ann Arbor, MI

Process Analytical Technology Implementation: A Project Management Based Approach
Dave Johnson and Paul Davies, Expo Technologies, Ltd., Columbia. MD

Lunch

Quality by Design: PAT Implementation of a Solid Dosage Form - Involved use of Light Diffraction System for Particle Size, NIRS for blend uniformity and NIRS for assay of Excipient and Drug in Final Dosage Form.
Pedro Hernandez, Ph.D., Wyeth Guayama, Puerto Rico

Case Studies Reviews - 3 groups (Continued)
Illustrated Case Studies Continue (with ProActive Involvement) defining the impact of PAT on Pharmaceutical/BioPharmaceutical Manufacturing

Discussion Leaders (Case Study Participants Include)
Rebecca Rodrigues, FDA, Rebecca Parrilla, FDA, Manolo L. Hormaza, Rodolfo J. Romanach, Ajaz Hussain, and David Gonzalez

Report on Discussions
Finalize
Meet to summarize

Take Home Messages
David Radspinner, Thermo, Ajaz Hussain, Sandoz, and Rebecca Rodriguez, FDA

Network Reception

Close - Day Two