SOP's for Bioanalytical Methods Validation

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.

Todd B. Graham
Instructor:
Todd B. Graham
Duration:
60 Minutes
Product Id:
502446
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
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Overview:

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
  • Consultants
  • 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.

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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