TBA The Biotechnology Initiative

The Voice of Bioscience in Ontario



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DESIGN OF EXPERIMENT - MAY 27, 2008 - TORONTO

COURSE OBJECTIVE: To update the knowledge of professionals from the pharmaceutical industries.

COURSE OUTLINE: Current and proposed changes in ICH guidelines and expectations of FDA and other regulatory bodies no longer can be met by the traditional approach in development and validation of drug manufacturing processes. This course will provide an opportunity to learn about the current and emerging statistical methodologies and quantitative approaches with recommendations and solutions appropriate for the pharmaceutical industry. The following topics, design of experiment, selection of design for formulation, process development or improvement of manufacturing process, data analysis, mathematical modeling and optimisation and the concept of "Six Sigma" , will be discussed in details.

COURSE LEADER: Dr. Umar Hayat, Ph.D. has over 10 years of combined experience in fellowship research and the pharmaceutical industry as a formulation scientist. He is Manager of Pharmaceutical Science at TransOral Pharmaceutical, located in California. Dr. Hayat received his MS and Ph.D. (Process Engineering) from Superior School of Chemical Engineering, France; his M.Sc. (Chemistry) from Punjab University and his postdoctoral fellowship from Polytechnic School, Canada. He has extensive research experience in the areas of controlled release drug delivery technologies, multi-layer tablets and gas liquid transfer in multi-phase systems.
As a Group Leader at Patheon Inc., he led a team of scientists involved in the formulation development of insomnia, cardiovascular and cancer drugs. He successfully implemented the concept of Design of Experiments -Six Sigma Quality Systems at Patheon TRO Operations. He also worked as Group Leader for Formulation and Process Development at Smartrix Technologies Inc.
Dr. Hayat is a member of the American Association of Pharmaceutical Scientists and the French Process Engineering Society. He is also a member of the Scientific Advisory Board of Oxford College, Canada.

WHO SHOULD ATTEND: This course is specially designed for all professionals working in the areas of QA/QC, R&D and Validation as associates, analysts, scientists, specialist, supervisors, managers and anyone who would like to strengthen their knowledge and expertise in statistics and design of experiment.

To register, visit the PSG website www.psg.ca or contact the PSG Office at 905-513-7743.