Forensic Toxicology Method Development and Validation

Utilising over 25 years of toxicology experience, Dr Simon Elliott of Elliott Forensic Consulting provides a comprehensive course relating to forensic toxicology method development and validation. The aim of the training is to provide more specific guidance in relation to method development and validation within analytical toxicology but the principles apply to various analytical disciplines. Across the 5-day course, delegates will gain an understanding of the various considerations and aspects including method selection, troubleshooting, quality control, validation planning/reporting, parameters and acceptance criteria. The course is suitable for practicing toxicologists and forensic scientists as well as those professionals interested in forensic toxicology.

COURSE OUTLINE

DAY 1

• Analytical Principles: detection, identification, calibration, internal standards, controls, good practice (e.g. replication, blanks)
• Method Selection: instrumentation
• Method Selection: sample extraction
• Method Selection: screening/measurement
• Method Troubleshooting
• Discussion pertaining to methods used by delegates + Questions and Answers

DAY 2

• Validation Planning: matrices, calibrators/QCs, equipment, parameters, timing, reporting
• Validation Parameters: selectivity/specificity 
• Validation Parameters: calibration - range, linearity & sensitivity
• Validation Parameters: limits of detection and quantitation 
• Validation Parameters: accuracy/bias and precision (between and within batch)
• Validation Parameters: ruggedness/robustness and measurement uncertainty 
• Validation Parameters: stability, carryover, matrix effect, recovery
• Discussion pertaining to validation planned/undertaken by delegates + Questions and Answers

DAY 3

• Acceptance Criteria: selectivity/specificity 
• Acceptance Criteria: calibration
  
• Acceptance Criteria: limits of detection and quantification
  
• Acceptance Criteria: accuracy/bias and precision (between and within batch)
  
• Acceptance Criteria: ruggedness/robustness and measurement uncertainty
  
• Acceptance Criteria: stability, carryover, matrix effect, recovery
• Validation Reporting
• Discussion pertaining to delegate experience + Questions and Answers

DAY 4

• Internal Quality Assurance: QC selection, levels, on-going monitoring, review, non-conformance and re-validations, etc
• External Quality Assurance: proficiency scheme selection, result review/acceptance, reporting, on-going monitoring, non-conformance, etc
• Intra & Interlaboratory testing
• Questions and Answers

DAY 5

• ISO 17025 laboratory accreditation considerations
• Further validation resources
• Questions and Answers