Bioanalytical Methods Validation

Why Should You Attend:

This presentation will examine and discuss recent changes in the FDA and EMA Bioanalytical Method Validation guidance, how they have changed, what features have been omitted but may still be relevant. Cautious guidance in observance of these documents to ensure successful method validation and compliance. For example, there is no description of system suitability, yet this is a given in assuring that the analytical system whether it is instrumental, ligand binding or cell based is performing within acceptance on each day of use before the validation experiment is run.

The attendee will learn what parameters are important and expected for instrumental techniques and what parameters may be applied to ligand binding and cell-based assays. Additionally, the attendee will learn about common pitfalls in method validation and how to reduce the risk and avoid them. This would include ensuring sufficient resources and time to meet validation requirements as well as to examine where quality by design may be implemented.

Areas Covered in the Webinar:

• Deciding when development is complete
• Preparation of controls for assay acceptance and stability
• Matrix Issues
• Ordering resources, columns, plates, primary and secondary antibodies, complimentary nucleic acids, cell types
• Rationale selection of interferences, including target enzymes and receptors, and metabolites
• Selection and implementation of parameters for system suitability
• Acceptances criteria for runs, stability, recovery and interference
• Implementing Quality by design during validation runs

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

Free Materials:

• FDA, EMA Guidance (web sites)
• Validation Checklist
• FDA 483 lists and specific 483
• Industry Best Practices Articles

Edward O'Connor
Individual Consultant, HJJ

Dr. O’Connor has been a Director, Manager and Consultant in regulated Analytical and Bioanalytical laboratories in Pharma, Biotech and CROs for over 25 years. He has had direct involvement in lab relocation and design, method development, method, process and instrument/equipment validation.

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