Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
Course - Los Angeles, CA, United States
Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex QC test methods to confirm manufacturing consistency and product quality. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies. The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays.
(Courtesy of Biopharmaceutical Analysis, via solvias.com)
Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control
Mon, Jun 17, 2013 - Tue, Jun 18, 2013
The Hilton Los Angeles Airport (LAX)
5711 West Century Blvd., Los Angeles, CA 90045, United States
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