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MAR
14

Validation of Bioanalytical Methods and Procedures for FDA Compliance

Conference
When the 14/03/12
Where Online Event
Description
This Validation of Bioanalytical Methods and Procedures training will demonstrate how to validate bioanalytical methods and procedures, in analytical laboratories, for FDA compliance.
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Price $299.00

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Agenda for Validation of Bioanalytical Methods and Procedures for FDA Compliance

Learning Objectives:

  • FDA regulations and guidelines.
  • Understanding the FDA and EMA Guidances for Bioanalytical Method Validation.
  • 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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