SOP's for Bioanalytical Methods Validation

Added 5 months ago by Joseph Wilcox on Health and Medicine
The webinar will include the following critical information you will need:

Defining what a bioanalytical method is
Necessary steps to validate an immunoassay
The challenges and opportunities of validating a molecular assay
Needs for mass spectrophotometry assays
Issues in transitioning between assay classes
Best practices for all bioanalytical 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.

Areas Covered in the Session
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
Bioanalytical Scientists
Pharmacokinetic Specialists
Biotech R & D staff
Clinical Research Associates
Regulatory Staff
Outsourcing Professionals
Biopharmaceutical Consultants
Speaker Profile
Todd B. Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities. During his time as a clinical laboratory scientist in his current role, he has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Event link:
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