Description

Method Validation and Verification for Chemical Analysis

(Covering Pesticide Residue, Contaminants & Nutritional Analysis)

Master the Essential Analytical Quality Tools for Reliable Chemical Testing in Food and Environmental Matrices

 

In the domain of chemical testing, the credibility of analytical results hinges on the rigorous demonstration that methods are fit for their intended purpose. This comprehensive training program provides a deep understanding of the method validation and verification process as required by ISO/IEC 17025:2017, with a specific focus on the estimation of various pesticide residues, toxins, and contaminants in food, agricultural, and environmental samples. By focusing on internationally recognized guidelines including SANTE 11312:2021, AOAC Guidelines, and ICH Guidelines, you will gain the competence to ensure the reliability, accuracy, and compliance of your laboratory's analytical methods. Through expert-led lectures, practical exercises, and real-world case studies, this course equips you to develop and validate methods for nutritional analysis as well as trace-level contaminants.

 

Actionable takeaways for your Job Role

By the end of this course, you will be able to confidently:

  • Interpret the Distinction between method validation and method verification, understanding when each is required under ISO/IEC 17025:2017.

  • Design and Execute a method validation study based on a risk-based approach, determining the appropriate extent of validation work based on the method's intended use and regulatory requirements.

  • Apply Key Guidelines including SANTE 11312:2021, AOAC, and ICH for pesticide residue, contaminant, and nutritional analysis.

  • Evaluate Performance Characteristics including specificity, selectivity, matrix effects, limit of detection (LOD), limit of quantification (LOQ), accuracy (recovery), precision (repeatability and reproducibility), ruggedness/robustness, linearity, and working range.

  • Verify Standard Methods effectively, demonstrating that your laboratory can achieve published performance parameters for the matrices to which methods are applied.

  • Understand Key Regulatory Concepts including Maximum Residue Limits (MRL), Minimum Required Performance Limits (MRPL), and the principles of dietary risk assessment (Hazard Quotient).

  • Apply Statistical Analysis Techniques regarding acceptance criteria and data verification and validation.

     

Quality & Excellence Performance Metrics

Post-training, you will drive these quality parameters to ensure operational excellence, in your job-role:

  • Successfully develop and implement validation and verification protocols for chemical test methods.

  • Thoroughly identify the performance characteristics that must be evaluated for different categories of test methods (identification tests, quantitative tests, limit tests, etc.).

  • Plan and execute validation studies with appropriate experimental design to minimize effort while maximizing confidence.

  • Implement robust procedures for evaluating matrix effects and performing appropriate matrix-matched calibration.

  • Update all critical documents including SOPs, validation/verification plans, and reports to reflect regulatory requirements.

  • Proactively identify and document risks to method performance and analytical reliability.

  • Investigate and implement corrective actions for non-conforming method performance.

     

Course Curriculum

The course is structured into focused modules, designed for optimal learning flow:

  • Module 1: Introduction to Method Validation and Verification: Definitions, Importance, and the ISO/IEC 17025:2017 Framework

  • Module 2: Key Guidelines and Regulatory Frameworks: SANTE 11312:2021, AOAC Guidelines, ICH Guidelines, and their Application to Pesticide Residue, Contaminant, and Nutritional Analysis

  • Module 3: Performance Characteristics for Chemical Methods: Detailed Interpretation of Specificity, Selectivity, Matrix Effects, LOD, LOQ, Accuracy, Precision, Ruggedness/Robustness, Linearity, and Working Range

  • Module 4: Method Validation Approaches: Interlaboratory vs. Single-Laboratory Validation, Extent of Validation Studies, and Statistical Design

  • Module 5: Method Verification: Verifying Standard Methods for Matrix-Specific Application, including Practical Exercises

  • Module 6: Practical Applications and Case Studies: Developing and Validating Methods for Multi-Pesticide Residue Analysis (QuEChERS), Contaminants, and Nutritional Analysis

 

Job Roles That Will Benefit

This course is essential for professionals involved in chemical testing, quality assurance, and regulatory compliance, including:

  • Quality Professionals and Laboratory Managers

  • Laboratory Analysts and Technicians

  • Food Chemists and Food Analysts

  • Researchers and Scientists in Chemical Analysis

  • Regulatory and Compliance Personnel

  • Trainers, Consultants, and Auditors

 

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a working knowledge of chemical analysis or prior experience in laboratory operations to maximize their learning from this course. Familiarity with quality management concepts is beneficial but not mandatory.

 

Course Features & Included Materials

  • Focused Content: Concentrate on the specific requirements for method validation and verification in chemical testing, with a focus on pesticide residues, contaminants, and nutritional analysis.

  • Interactive Sessions: Engage in practical exercises with real-life scenarios and case studies on method development and validation.

  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced chemical testing and accreditation professionals.

  • Comprehensive Learning Materials: Digital Learning Materials covering key guidelines, performance characteristics, statistical techniques, and validation/verification templates.

  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training Evaluation.

  • Certificate of Training: Earn a verifiable, with a unique ID and QR code, soft-copy certificate issued via the QCI training portal. Validate your achievement anytime at https://pathshala.qcin.org/.

 

Enroll Today and Lead Your Laboratory to Analytical Excellence and Regulatory Compliance!

Gain the confidence to develop, validate, and verify robust chemical test methods, ensuring reliable results and demonstrating technical competence to clients and accreditors.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org or call +91 97735 00376.