This training on bio-analytical methods validation will help you understand the clear, consistent and compliant approaches for instrumental, ligand binding, and cell based methods. A comparison of EMEA and FDA guidances will be presented.
Why should you Attend:
Bioanalytical method validation includes various procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use. It is essential to employ well-characterized and fully validated bioanalytical methods to yield reliable results which can be satisfactorily interpreted.
This webinar will discuss the best practices of Bioanalytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability. Concept of plate and experiment separation. Importance of communication between the development and the validation labs, accuracy of transfer documents (SOPs). Predicate rules, support of clinical and non clinical sample analysis.
Understand - Is validation a regulated activity? When to pull the trigger for validation? Is a stable label internal standard always the best choice? Importance of suitability testing. Value of including critical reagents testing and suppliers. The limits of an assay and where they come from.
Added by complianceonlinecom on March 5, 2013