In this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods.
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.
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
- 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
Who Will Benefit:
- 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
Instructor Profile:
Edward O’Connor, PhD, is a consultant supporting Bioanalytical method development, validation and application to non clinical and clinical sample analysis. His background includes directing these efforts at a number of CROs including Tandem Labs, TherImmune, Covance, Oread and Mason Research. In addition, Dr. O’Connor directed, or managed validation efforts and samples analysis at Elusys, Biogen and MedImmune.
