SOP's for Bioanalytical Methods Validation

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.

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.

• 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
• Documenting and archiving raw and source data
• Considerations for Microbiological and Ligand-binding Assays
• Working with QC samples for quantitative results
• To revalidate or not after method changes
• Transferring and using the method to routine
• Using computers for automated method validation
• Documentation for the FDA and other agencies

• Managers and analysts in bioanalytical laboratories
• Managers and analysts in forensic and toxicological laboratories
• QA managers and personnel
• Validation specialists
• Training departments
• Documentation department
• Consultants
• Bioanalytical scientists
• Pharmacokinetic specialists
• Biotech R & D staff
• Clinical research associates
• Regulatory staff
• Outsourcing Professionals
• Biopharmaceutical Consultants