Analytical Method Qualification, Transfer, and Validation for Biosimilars
June 22, 2016 - Baltimore MD USPDA
elliott@pda.org
Phone:301-656-5900
This course will provide the attendants with an understanding how risks can be consistently assessed from available data sources and how this can be applied to each method lifecycle step. At the end of this course, the attendants will be able to generate suitable protocols and acceptance criteria. Future regulatory submissions will be more robust and regulatory inspections can be readily passed.
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