ComplianceOnline

Bioanalytical Methods Validation - Incorporating EMA and FDA Guidance as well as other concerns

Instructor: Edward O Connor
Product ID: 701769
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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 guidances will be presented.

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 as well as Biotechs MedImmune, Biogen and Elusys.

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