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Biotech 2012 - Accelerating Bioassay Transfer in a GMP Environment

Date2012-02-23

Deadline2012-02-23

VenuePalo Alto, USA - United States USA - United States

KeywordsAssay Transfer; Transfer of Bioassays; GMP/GLP labs; validated assays; non-validated assays; biological assays transfer

Websitehttp://www.complianceonline.com/ecommerc...

Topics/Call fo Papers

This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.
Why Should You Attend:
50% of the drugs presently in discovery are biopharmaceuticals - these numbers lead to an "outsource or perish" philosophy for GMP/GLP development, validation and sample analysis. Unlike synthetic drugs requiring only straightforward analytical testing biopharmaceuticals require more elaborate assays to attain regulatory compliance. The industry has a significant underestimation of the discipline; skills and planning required to successfully transferring these assays. Naiveté in this area causes loss of precious time and money during development.
Areas Covered in the seminar:
This webinar systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development. Topics to be addressed are:
- Setting a realistic timeline for your assay transfer.
- Issues that need to be addressed in preliminary discussions between the labs.
- Proper method writing.
- Parameters to be evaluated during transfer - the transfer protocol.
- Transfer report.

Last modified: 2011-12-08 20:06:32