Event Date/Time: Nov 01, 2005 End Date/Time: Nov 02, 2005
Registration Date: Oct 28, 2005
Early Registration Date: Oct 01, 2005
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Conference Objectives

Stay Current
Modern pharmaceutical technical operations are changing and evolving very rapidly. Many companies are involved in improving and enhancing operation techniques and exploring alternatives that are more efficient to reduce testing time, either on the production floor or in the analytical laboratory.
By staying current with the latest good new advances, such as PAT, you will help ensure your organization compliance and competitiveness.
Our intensive 2-day conference and exhibition with workshops will provide you with an update of practices and technologies that are shaping today’s pharmaceutical and biopharmaceutical technical operation needs.

Who will Benefit?

Pharmaceutical and Biopharmaceutical, who have some background in validation (at least one year) and need a step-by-step, in-depth understanding of validation, especially within:
Quality Assurance
Product/Process Development
Process Control
Technical services
R & D
Analytical Development/Sciences
Research/Compliance Auditing
Validation Engineers
This course is also of interest to Equipment Contractors, Consultants and contract research organizations that specializes in Process Validation, Quality Assurance, Regulatory Affairs and Automation.

Why you should attend?

Improve Your On-the-Job Performance Through sound understanding of the following:
1. Develop a sound understanding of streamlining Validation
2. Develop a good understanding of the different modern methods that are available now
3. Learn how to qualify an autoclave efficiently?
4. Develop a good understanding of critical primary packaging.
5. Develop a good understanding of how the validation paradigm is changing with the new quality concepts?
6. Discover what is thermal Effusivity ?
7. Learn how to establish valid sampling, testing and release specifications through our pre-conference course.
8. Learn the important factors in computer assisted chromatography.
9. Learn about the Impact Areas a LIMS can have on your Laboratory
10. Get in-depth knowledge about PAT and how will it change the validation paradigm?
11. Learn about GMP electronic notebook systems for the “Paperless” 21st Century cGMPs
12. The case studies and workshop will be discussed in interactive group participation along with the panel of experts.
13. Learn from experts in the field, how to develop a robust dissolution method ?
14. Learn what is six sigma and how can it be applied in the pharmaceutical industry, a very useful modern tool?


Robert A. Nash , Ph.D. is presently a consultant and adjunct professor of Pharmaceutical Engineering at Stevens Institute of Technology, New Jersey.

Ady Sadek , M.Sc., P.Chem is presently president of proGamma Science Corporation

Alexander Bliu -M.Sc. Statistics & Math.is s presently senior biostatistician at Center for Biologics Research with Health Canada.

Ken Rapp , President and CEO of VelQuest Corporation, USA

Samia Gamati, Ph.D. – is presently Director of R&D and Quality at Groupe Sodexen

Saeed Qureshi , Ph.D Health Canada
Dr. Qureshi is a senior research scientist at the Therapeutic Products Directorate, Health Products and Food Branch, Ottawa, Canada

Rodolfo Romañach, Ph.D
Dr. Romañach is currently Professor of Chemistry at the University of Puerto Rico

Yves Roy, Ph.D. Mathis Instruments

Kevin Suich, North East Director of Informatics, Perkin Elmer , USA

Laura Bush is managing editor of Pharmaceutical Technology

Shams Rustom , M.Pharm, R.Ph.
Currently is Director of Process Development & Contract Manufacturing at Labopharm

David Tozer, Ph.D., CQE, Six Sigma black belt

Omar Osman , M.Sc., Six Sigma Master Black Belt, President of Innovance Inc.


Additional Information

-October 31,2005 a preconference course: Essential Statistical Tools For Process Validation and Quality Assurance For pharmaceutical and biopharmaceutical - November 1st,2005 Plenary session -November 2, 2005 Exhibition will be opened from 9 am to 5pm workshops on PAT and Modern Analytical and Laboratory Automation