Bio-analytical Method Validation- What does the FDA expect

Edward 'O' Connor

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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:

This webinar will review target areas addressed by FDA and EMA current guidance documents and ICH requirements. Current interpretation of guidance documents including failed runs, single stocks for standards and controls. Will address requirements for LC-MS, ligand binding and suggest requirements for cell based assays.

This Webinar will provide a review of current guidance documents for bioanalytical method validation to establish methods for the analysis of active pharmaceutical ingredients, metabolites and carrier components in biological materials. Recent 483s covering stability, single stock use and reporting of failed results will be discussed in detail, and approaches to avoid 483s will be presented. Web References to documents will be provided.

Areas Covered in the Webinar:

  • FDA and EMA current guidance documents and ICH requirements
  • Requirements for LC-MS
  • Ligand Binding and Cell Based Assays
  • Validation Considerations
  • Current target areas for 483s

Who Will Benefit:

  • Managers and analysts in bioanalytical laboratories
  • QA and QC managers
  • Validation specialists
  • Training departments
  • Study Directors
  • CRAs
  • CRM
  • Sponsors
  • IT support
  • R&D staff
  • Regulatory staff
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Edward 'O' Connor,

Ed'O'Connor is currently senior consultant for Aegis Bio consulting. He has over 20 years in regulated bioanalysis serving in Director or manager level roles in Biotech at Alexion, Elusys, Biogen and Medimmune and At CROs including Matrix, Tandem, Therimmune and Covance. He has a PhD in Zoology from UMass Amherst and a BS degree from Texas A&M Commerce. His post-doctoral training focused on the neuroendocrine system in health and disease. 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 Biotech's MedImmune, Biogen and Elusys.

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