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Morning Session

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Regulatory – QbD Submissions
Interaction with the FDA

Chair: Dominic Ventura

Introduction and Opening Remarks
Dominic Ventura, Ph.D., Vice President Process Excellence, Wyeth
Pharmaceuticals

Improved Process Understanding for Late-Stage Drug Product Development using QbD/PAT Principles and Tools
Jun Huang, Saly Romero-Torres and Pedro Hernandez, Principal
Scientist II-PAT, Wyeth Pharmaceuticals, Pearl River, NJ

What might QbD look like in Bio Manufacturing
Vincent L. Vilker, Director, OTR, OPS, CDER, FDA, Silver Spring, MD

Routine LC analysis on the Manufacturing Floor: New Technology for Real-Time Process Reaction Monitoring, Process Chromatography Analysis, and Cleaning Validation
Craig Dobbs, Waters Corporation, Milford, MA

Deliverables:

1. Learn about QbD in Bio Manufacturing.
2. Examples of successful application of QbD and PAT Principles for Late Stage Product Development.
3. Opportunities for Using Liquid Chromatography in PAT.

Lunch

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Afternoon Session

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PAT and QbD Implementation

Chair: Dominic Ventura

Transforming Pharmaceutical Manufacturing with PAT & QbD
Carlos Conde-Reyes, PAT Director, Wyeth, Guayama, PR

Chemometrics in PAT; A Six Sigma Perspective
Charles E. Miller, Ph.D., Eigenvector Research

PAT in Biomanufacturing
(TBC)

Panel - Progress in PAT in Puerto Rico’s Pharmaceutical Industry
Manuel Hormaza, PR PAT Service Provider, Carlos Conde, PAT Implementation in Pharma, Rodolfo Romañach, PAT Developer en Academia, Dominic Ventura, Long Time PAT Leader and Charles E. Miller, Eigenvector Research

Deliverables:

1. How to structure pharmaceutical manufacturing in support of PAT & QbD initiatives.
2. Understand the relationship between PAT and Lean Six Sigma Manufacturing.
3. Implementing QbD principles in the biotechnology industry.
4. How to progress towards real time release.

Reception

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Morning Session

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Engineering Based on Quality by Design

Chair: Carlos Velázquez, Ph.D., UPRM

A Quality by Design Approach to Continuous Manufacturing of Tablets
Fernando Muzzio, Professor II, Department of Chemical and Biochemical Engineering, Rutgers University & NSF-Engineering Research Center for Structured Organic Particulate Systems, New Brunswick, NJ

Development, implementation and validation of PAT for the Pharmaceutical Manufacturing community: What is the role of the vendor?
Paul Davies, Expo Technologies, Columbia, MD

A Quality by Design Approach to Control Systems
Carlos Velázquez, Ph.D., Department of Chemical Engineering & NSF Engineering Research Center for Structured Organic Particulate Systems, UPR-Mayagüez

Deliverables:

1. Advantages of continuous manufacturing, and control strategies.
2. Learn strategies for control systems for QbD manufacturing processes.

Lunch

Afternoon Session

Implementing Spectroscopic Methods in Industry

Chair: Manuel Hormaza, IBS Caribe

Implementation of NIR Methods in a Pharmaceutical Environment
Angel R. Martinez, Scientist IV, Wyeth Consumer Products

PAT Data Management: Now that We Have PAT – What do we Do with the Information, (TBA), ABB

Raman Methods for Bio-processes
Manuel Hormaza, IBS Caribe

A Procedure for Development of Quantitative NIR Methods and its Application to a Potent Drug Formulation”
Joshua León Ricardo, Rodolfo J Romañach, Department of Chemistry & NSF Engineering Research Center for Structured Organic Particulate Systems, UPR-Mayagüez

Deliverables:

1. Procedure for implementing quantitative NIR methods.
2. Learn about industries’ experience in implementing NIR methods. Opportunities for reducing implementation time.
3. NIR, Raman for process monitoring.
4. Going beyond process monitoring: PAT data management systems, and how to use them to improve processes.

Exhibits (Table Tops) Tuesday June 23 and Wednesday June 24, 2009