Bioanalytical Methods Validation 2013

Topics

• Learning from the Crystal City FDA/Industry conference report.
  • 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 results
  • Using computers for automated method validation
  • Transferring and using the method to routine
  • Documentation for the FDA and other agencies
• FDA regulations and guidelines

Who should Attend

• Managers and analysts in forensic and toxicological laboratories
• Managers and analysts in bioanalytical laboratories
• Validation specialists
• QA managers and personnel
• Documentation department
• Training departments
• Bioanalytical scientists
• Consultants
• Biotech R&D staff
• Pharmacokinetic specialists
• Regulatory staff
• Clinical research associates
• Biopharmaceutical Consultants
• Outsourcing Professionals