This Bioassays training/webinar will 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.
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.
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.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.
Areas Covered in the seminar:
This seminar 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
Who Will Benefit:
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.- Bioassay and Analytical Scientists
- Pharmacokinetic/Pharmacodynamic Scientists
- Outsourcing Professionals
- Project Management
- Regulatory Staff
- QA/QC
- Consultants
Course Provider
Ana Menendez,
