Validation of Ligand-Binding Assays. Building confidence and compliance together.

The recording from the Validation of Ligand-Binding Assays. Building confidence and compliance together is available now.

Information

During this Webinar we will show with several real examples of how to design and analyze experiments for the validation of a Ligand-Binding assay to ensure it will provide compliance with most criteria required by regulations such as ICH, FDA and USP.

In addition, an intuitive explanation of the various validation criteria required will be provided to build confidence in the decision to claim your assay is valid and therefore providing the laboratory as well regulatory authorities that results can be trusted in the future routine use. A fit-for-purpose understanding of fundamental concepts such e.g. Accuracy, Precision, curve-fitting choices and parallelism will be given with examples. Also, a global perspective will be given for the Ligand-Binding Assay: the use of the results it produce, defining specification limits and reducing risk to reject results in routine and preparing its future transfer. The 'Accuracy Profile' will be introduced as an effective data-driven decision tools.

Increase confidence in results produced by your assay:

• Experiments to conduct for validation
• Providing the right measures of performance
• Fit-for-Purpose decision making for curve and quality
• Understanding and controlling risk to produce results out-of-specifications

Ensure regulatory compliance of your Ligand-Binding Assay:

• Understand the true meaning of regulatory requirements
• What need to be reported, and how
• Quality is not only documenting
• Avoid misinterpretation and get your assay under control again

Presenters

Speaker: Bruno Boulanger, CEO, Arlenda and Senior Lecturer, Statistics, School of Pharmacy, University of Liège