Validation of Bioanalytical Methods and Procedures for FDA Compliance 2012

• Understanding the FDA and EMA Guidances for Bioanalytical Method Validation
• FDA regulations and guidelines
• Logistics of validation
• Phased approach for validation during drug development
• Preparation and use of reference standards and equipment
• Development of a master plan and SOP for validation
• Defining validation experiments
• Defining parameters and acceptance limits
• Considerations for Microbiological and Ligand-binding Assays
• Documenting and archiving raw and source data
• To revalidate or not after method changes
• Working with QC samples for quantitative routine analysis
• Using computers for automated method validation
• Transferring and using the method to routine
• Documentation for the FDA and other agencies

Validation of Bioanalytical Methods and Procedures for FDA Compliance 2012 brings together Managers and analysts in forensic and toxicological laboratories, Managers and analysts in bioanalytical laboratories, Validation specialists, QA managers and personnel, Documentation department, Training departments and Consultants.