Accelerating Bioassay Transfer in a GMP Environment - Webinar By ComplianceOnline (Biotech Training)
Venue: Online Event
|Event Date/Time: Feb 23, 2012||End Date/Time: Feb 23, 2012|
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. NaivetÃ© in this area causes loss of precious time and money during development.
Participants in this seminar will attain a valuable checklist of critical information that will reduce delay and confusion during method transfer. The hands-on, common sense approach will provide a chronological pathway that can easily be adapted for any complex assay.