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Conference Directory
Phase Specific Validation of Potency Bioassays
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Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Bioassay and analytical scientists,Validation specialists,Project Management,Regulatory staff,QA/QC,OutsourcingProfessionals,Consultants
Start Date of Conference:: 01-14-2010
End Date of Conference: 01-14-2010
Description of Conference: Learn the current regulatory guidances in USP1034 chapter of analyzing bioassays, and USP1033 chapter of bioassay validation and know how to take the potency bioassay from pre-clinical development throughout final commercial implementation.
Areas Covered in the seminar:
* Differences between qualification and validation.
* Situations when can a binding method be used.
* Timeline and expectations for Master and Working Cell Banks.
* Overview of USP1034 chapter of analyzing bioassays.
* Overview of USP1033 chapter of bioassay validation.
* Phase appropriate specifications for system suitability.
* Implementation and interpretation of process charts.
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2009 
