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PRA2010 Chemistry, Manufacturing and Control

The objective of this course is to provide a strong understanding of the importance and underlying principles for CMC requirements from the regulatory perspective. Participants will learn to develop a cost effective, risk managed CMC regulatory compliance strategy to move these products into commercialization and maintain CMC regulatory compliance once market approval has been obtained. The course also covers in depth discussion of international food and drug laws, regulations and guidelines.

This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Regulatory Affairs Departments.

Online Education Registration CAD$450 +HST

PRA2010 Chemistry, Manufacturing and Control

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