ISPE Conference on Manufacturing Excellence
25-28 February 2008
Hyatt Regency Tampa
Tampa, Florida, U.S.
The Impact of PAT-oriented Process Development and Manufacturing Operations on Data Management
| 25-26 February 1.2 CEUs |
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Since the launch of the PAT initiative a few years ago, many articles have been written, lectures given, and training courses developed around the concept and its implementation in the global biopharmaceutical industry. But one of the most critical questions is what to do with all of the additional data that is being generated. This session looks at the progress that has been made and the technologies being applied to manufacturing processes with a focus on management of the data generated.
This seminar concentrates on how PAT systems are being implemented to design, analyze, and control manufacturing operations in new ways that are changing the way scientists and engineers develop products and processes. We will use case studies to understand how companies have utilized data management throughout their manufacturing environment through the use of case studies.
The final afternoon will be devoted to fully interactive PAT COP activities. ISPE’s Communities of Practice (COPs) are professional groups each focused on one broad area of the industry. COPs provide enhanced connectivity through a vibrant, interactive community offering global networking opportunities and access to a community-specific Body of Knowledge. The COPs also work on projects in an endeavor to move their segment of the industry forward. For more information visit www.ISPE.org/COPs.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Understand the data management behind PAT and QbD
- Justify data management PAT/QbD projects in your organization knowing the drivers and benefits
- Know how to structure, initiate and implement PAT data management projects based on presented case studies
- Know how to evaluate PAT/QbD data and generate additional value out of it
- Find about activities relating to analytical device integration via OPC
- Understand how PAT/QbD data management is done in the industry based on case studies
- Enhance your network of people with PAT/QbD knowledge
- The ability to ask all of your questions related to PAT/QbD data management
Who Should Attend
Process engineers, controls engineers, manufacturing IT specialists, production engineers
Community of Practice (COP)
Process Analytical Technology (PAT)
GAMP
Related Technical Documents
ICH Q8, Q9, and Q10
ISPE Document: Create QbD/PAT Awareness Document (Result of the German/Austria/ Switzerland Affiliate)
ASTM E55
OPC Standard
Seminar Leaders
- Kevin Klopfer, PhD, Associate Director, Manufacturing Operations, Celgene Corporation
- Christian Woelbeling, Dir Marketing & Sales, Werum Software & Systems
Speakers
- Ali Afnan, PhD, Process Analytical Technologist, FDA/CDER
- Thomas Buijs, Product Manager, ABB
- James Cheney, Director, Global PAT, Novartis Pharmaceuticals
- David Gibson, Assoc Dir, Pharma Dev Center & PAT, Wyeth Medica Ireland
- Frederik Jaenen, Team Manager, Siemens
- Dave Johnson, Vice President, Expo Technologies LLC
- Gawayne Mahboubian-Jones, Product Development Mgr, Optimal Automation LLP
- Chris McCready, PAT Program Manager, Umetrics
- Justin Neway, PhD, Chief Science Officer, Aegis Analytical Corporation
- Cenk Undey, PhD, Principal Engineer, Amgen Inc