IFPAC '04 Summer Summit
July 27-29, 2004
Westin Rio Mar Resort Hotel
Rio Grande, Puerto Rico
Efficient pharmaceutical manufacturing is a critical part of an effective U.S. health care system. Process Analytical Technology...the System for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw, in-process materials and processes with the goal of ensuring final product quality. The ultimate goal of PAT is to understand and control this manufacturing process.
OrganizationsColegio de Quimicos de Puerto Rico (CQPR) is the official organization of professional chemists and scientists in Puerto Rico. The PAT Symposium will be held as part of CQPR’s annual meeting. IFPAC is an international organization dedicated to the advancement of PAT.
BenefitsLearn the practical aspects of PAT, Process Analytical Technology as it is applied to the Pharmaceutical Manufacturing Environment. PAT is understanding the Process for innovative pharmaceutical manufacturing and continuous quality assurance. Real Applications or Case Studies will be used to clearly illustrate the key components and the benefits of PAT - Process Analytical Technology.
Broaden your knowledge about the PAT initiative, and how industry is responding to the PAT opportunity. Established and emerging PAT applications and technologies for the Pharmaceutical Industry will be described.
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Process Analytical Technology
Tuesday 27 July, 2004 |
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Afternoon Program: PM
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PAT – Pharmaceutical Manufacturing in the Future |
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Process Analytical Technology
Wednesday, 28 July, 2004 |
| Morning Program: AM-I James K. Drennen III, Ph.D., and Ken Leiper, Benson Associates, Granthan, UK |
Introduction and Opening Greetings Pharmaceutical Manufacturing is Changing: You Can Sense It Carmel Egan, Ph.D., Vice President, Manufacturing Science & Technology, Eli Lilly and Company, Indianapolis, IN Process Analytical Technology: PAT in Scale-Up Patrick Hyett, GlaxoSmithKline, Harlow, Essex, UK Break PAT and Quality by Design: A Pharmaceutical Industry Perspective. Gerry Migliaccio, Vice President of Quality, Pfizer, Inc., Groton, CT Process Characterization for BioPharmaceuticals: A Case Study Jim Seely, Marcus Luscher, Amgen, Inc., Longmont, CO |
| Afternoon Program: PM-I Dan Klevisha, Bruker Optics, Billerica, MA |
Case Study: Leverage Process Information to Advance Pharmaceutical Manufacture: Obtaining, Analyzing & Summarizing Drug Product Data to Improve Process Efficiency, Cost and Quality Jean-Marie Geoffroy, Ph.D., Abbott Laboratories, Manufacturing Sciences, Global Pharmaceutical Operations, Technical Operations Support, N. Chicago, IL Case Study II: MicroBiology Applications of PAT Bryan S. Riley, DHHS/FDA/CDER/OPS, Rockville, MD Break PAT: The Technology Being Developed University Speaker ( (Dr. Rodolfo Rodolfo Romanach, Dr. Carlos Velazquez, or Dr. Samuel Hernandez, UPR, Mayaguez ) Technology Application of PAT Dan Klevisha, Bruker Optics, Billerica, MA Open Forum Discussion Questions |
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Process Analytical Technology
Thursday, 29 July, 2004 |
| Morning Program: AM-II James K. Drennen III, Ph.D., and Ken Leiper, Benson Associates, Granthan, UK |
Introduction & Opening Greetings The Implementation of PAT in the Pharmaceutical Industry: Regulatory Incentives and Opportunities Ajaz S. Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science, CDER, FDA, Rockville, MD The Implementation of PAT in the Pharmaceutical Industry: Methods and Analysis (TBA) James K. Drennen III, Ph.D., Duquesne University, Center for Pharmaceutical Technology, Pittsburgh, PA Break The Implementation of PAT: Managing Risk (Risk Based Process Validation) Ken Leiper, Benson Associates |
| Afternoon Program: PM-II |
PAT Inspections/Submissions: Issues and Challenges Rebeca Rodriguez, National Drug Expert Investigator, DFI/ORO/ORA/FDA Break Open Forum- Discussion and Questions for the panel Close |