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ComplianceOnline, Online Event
2013-03-29
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.
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
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Organized by:
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Complianceonline |
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Invited Speakers:
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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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Deadline for Abstracts:
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2013-03-28
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Registration:
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For Reg: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701769?channel=Hummolgen
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E-mail:
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referral@complianceonline.com
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