Analytical Method Validation and Transfer 2019

Topics

• Analytical Method Pre-Validation - Stage 1
  • ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
  • Analytical Target Profile (ATP)
• Regulatory Requirements/Guidance on Analytical Method Validation
  • FDA, EMA, ICH requirements and guidance
  • Terminology defined: qualification, validation, revalidation and verification
• Test Method Validation Protocol
  • Pre-planning and planning steps
  • Elements of a validation protocol
• Analytical Method Validation Characteristics - Stage 2
  • LOD and LOQ
  • Specificity, accuracy, precision, linearity, range
• Test Method Validation Report
  • Elements of the validation protocol and the associated final validation report
  • Elements of the validation report

Who should Attend

• Quality Control Departments
• Quality Assurance Departments
• Validation Departments
• Regulatory Affairs Departments
• Analytical Development Teams