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.

Areas Covered in the Seminar:

• FDA regulations and guidelines.
• Learning from the Crystal City FDA/Industry conference report.
  • Phased approach for validation during drug development
  • Logistics of validation
  • Development of a master plan and SOP for validation
  • Preparation and use of reference standards and equipment
  • Defining parameters and acceptance limits
  • Defining validation experiments