SOP’s for Bioanalytical Methods Validation

Clinical laboratories, research and development facilities as well as quality control and manufacturing have one thing in common- they all use Bioanalytical assays in their laboratory. These laboratory assays have become crucial to the regular operations of all sorts of laboratories. However, transitioning from one assay to another is not a simple task and comes with its own set of challenges. Bioanalytical Methods Validation involves understanding each type of bioanalytical assay and what particular challenges and opportunities it presents. This would ensure validations are successfully completed. Three broad classes of bioanalytical assays will be covered: immunoassays, molecular assays and mass spectrophotometry based assays. We will analyze each of their particular advantages and challenges in their class as well as how to operate within each class. The challenges in moving between classes will also be evaluated. This will ensure that assay validation goes off without a hitch, and new assays can be deployed in a timely manner.

Areas Covered in the Session :

  • 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
Who Should Attend:

  • Research and Development Departments
  • Quality Control Departments
  • Assay Development Departments
  • Assay Validation Departments
  • Documentation Departments
  • Clinical Diagnostics

FDB3110

Todd Graham

Todd 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.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. Todd has written a number of market research reports used by Fortune 500 biotechnology firms in strategic planning, and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities, and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd Graham graduated in 2006 with a MA in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.

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