Analytical Method Validation and Verification

Programme Summary

Design method studies that demonstrate fitness for the intended analytical decision. Participants distinguish validation from verification, select relevant performance characteristics and plan experiments using realistic laboratory data. Practical exercises address precision, bias, range, detection capability and robustness, producing a justified study plan and a clear report that supports routine method introduction and controlled change.

Training Objectives

1 Connect analytical performance with intended use; 2 Select proportionate validation and verification studies; 3 Strengthen experimental design and acceptance criteria; 4 Evaluate performance data and technical limitations; 5 Support controlled introduction of laboratory methods.

Learning Outcomes

1 Define measurable analytical performance requirements; 2 Prepare a validation or verification protocol; 3 Calculate precision bias and working range; 4 Interpret detection capability and robustness evidence; 5 Write a justified fitness for purpose conclusion.

Target Audience

Analytical Chemists; Method Development Scientists; Laboratory Supervisors; Validation Specialists; Laboratory Quality Managers.

Target Industries

Chemical Testing Laboratories; Food Testing Laboratories; Pharmaceutical Quality Laboratories; Environmental Testing Laboratories; Petrochemical Testing Laboratories.

Course Contents

• Module 1 Intended Use and Decisions: Measurand matrix and reporting needs; Customer limits and target performance; Validation versus verification scope.
• Module 2 Planning the Study: Performance characteristics and study sequence; Acceptance criteria established before testing; Resources responsibilities and controlled protocol.
• Module 3 Samples and Reference Materials: Representative matrices and concentration levels; Reference values and material suitability; Replicates independence and sample stability.
• Module 4 Precision Studies: Repeatability and intermediate precision design; Variance estimates and relevant conditions; Precision criteria and practical interpretation.
• Module 5 Bias and Recovery: Reference material and spike studies; Recovery relevance and matrix effects; Significance interpretation and correction decisions.
• Module 6 Calibration and Working Range: Calibration models and residual patterns; Linearity limitations and weighting choices; Range verification and dilution integrity.
• Module 7 Detection and Quantification: Detection capability and decision context; Blank variability and low level performance; Verification of quantification reporting limits.
• Module 8 Selectivity and Interferences: Matrix components and potential interferents; Selectivity challenges and identification evidence; Interference controls and residual limitations.
• Module 9 Robustness and Method Transfer: Deliberate variation of critical factors; Transfer conditions and laboratory comparability; Triggers for additional validation work.
• Module 10 Data Quality and Calculations: Outlier review with scientific justification; Transparent calculations and retained raw data; Uncertainty links and performance summaries.
• Module 11 Reviewing the Validation Report: Comparing results against predefined criteria; Scope restrictions and unresolved deviations; Authorised conclusion and implementation decision.
• Module 12 Validation Planning Workshop: Constructing a quantitative method protocol; Evaluating a supplied performance dataset; Defending the fitness for purpose conclusion.

Assessment

• 60 single best answer questions, including applied scenarios; one mark per question.
• 90 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Supplied reference pack and calculator permitted; external internet and AI prohibited.
• Individual applied assessment (45 minutes): Prepare a method study protocol and analyse a supplied validation dataset to justify whether the method is fit for its stated purpose.
• Assessment criteria: Appropriate study design and criteria; Correct analysis of performance data; Defensible method suitability conclusion.
• Pass each component separately: 45/60 written marks (75%) and at least 70% on the applied task.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records analytical validation planning and interpretation skills; approval of a laboratory method remains the responsibility of authorised technical personnel.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

333

Total teaching hoursTotal teaching hoursTotal teaching hours

18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.18 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 16 delegates.Maximum 16 delegates.Maximum 16 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Analytical laboratory experience and basic statistics are required. Participants should understand the operating principles of a quantitative test method.Analytical laboratory experience and basic statistics are required. Participants should understand the operating principles of a quantitative test method.Analytical laboratory experience and basic statistics are required. Participants should understand the operating principles of a quantitative test method.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Review a supplied method and complete a 30-minute diagnostic on precision, bias and analytical range.Review a supplied method and complete a 30-minute diagnostic on precision, bias and analytical range.Review a supplied method and complete a 30-minute diagnostic on precision, bias and analytical range.

End of course assessmentEnd of course assessmentEnd of course assessment

60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).60 question written exam (90 minutes) and individual applied task (45 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.