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Analytical Method Validation
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Analytical Method Validation

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.

6/1/2015 to 6/2/2015
When: June 1-2, 2015
9:00 a.m. - 5:00 p.m.
Where: The Hilton Los Angeles Airport (LAX)
5711 West Century Boulevard
Los Angeles, California  90045
United States
Contact: Olivia Carlin
610.648.7550

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Analytical Method Validation for Biologics, Biopharmaceuticals, and Other Therapeutic Products

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. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion. 

 

Learn more about the course and register.


CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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