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Validity : 20th Apr'24 to 30th Apr'24
SOP's for Bioanalytical Methods Validation
- 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
Overview of the webinar
This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease. 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 guidance’s will be presented.
Who should attend?
- 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
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. The concept of plate and experiment separation. Importance of communication between the development and the validation labs, the accuracy of transfer documents (SOPs). Predicate rules, support of clinical and non-clinical sample analysis.
Faculty - Mr.Todd Graham
Todd Graham, is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. Mr. Graham has work for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries. He has a broad level of expertise in assay development for quality control, pharmaceutical development and clinical diagnostics. His particular levels of expertise are molecular diagnostics, PCR, ELISA, quality control and training of bench level personnel in clinical diagnostics and biotechnology. He is also in the process of establishing a consultancy that assists academic labs in transitioning their research to industry by verifying and improving the quality of their work.