Validation of analytical methods

Validation of analytical methods

Details

  • Start date: 21 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 22 December 2022
  • Finish time: 14:00 (Kyiv)
  • Duration: 2 days, 8 academic hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    ₴4500/€225 (pre-sale until 14.12.2022) + ₴900/€45 for each next participant;

    ₴5000/€250 (from 14.12.2022) + ₴1000/€50 for each next participant

     

    Course description: Validation of analytical methods is an important step in the quality assurance of analytical measurements, which provides confidence that a particular method is suitable for practical application. This process is required by ISO/IEC 17025 as well as many other regulations and directives. The training course will cover the main documents and guidelines for method validation, the main validation parameters and how to evaluate them, planning a validation experiment and writing a report. The course includes the basics of statistical methods required for planning and interpreting validation data, as well as many practical examples with processing in Excel.

     

    Target audience: the workshop is intended for employees of testing laboratories in the food industry, pharmaceutical companies, laboratories working in the field of environmental monitoring.

     

    In a programme:

    Day 1

    • Validation of analytical methods. Validation goals. What methods are subject to validation.

    • Basic guidelines for the validation of analytical methods. Regulations and good practices.

    • Basic validation parameters.

    • Validation and verification of analytical methods.

    • Basic statistical procedures used in the validation of analytical methods.

    Practical part:

    • Calculation of statistical parameters.

    • Combining standard deviations and other useful statistical procedures.

    • Significance tests.

    • Interpretation of statistical test results.

    • Linear and quadratic regression. Interpretation of results and possible errors.

     

    Day 2

    • Validation protocol. Plan of experiments to evaluate the correctness and precision.

    • Precision of measurement results, types of precision, quantitative characteristics of precision. Evaluation of the precision of the results. Approaches to Precision Evaluation (SPU vs ISO 5725).

    • Correctness of results. Assessment of correctness, quantitative characteristics of correctness. Interpretation of the results of the assessment of correctness.

    • Linearity and operating range of the technique.

    • Limit of detection and limit of quantitation.

    Practical part

    • Processing of the results of the experiment to assess the precision of the results and interpretation of the data.

    • Processing of the experiment to evaluate the correctness of the results and interpretation of the data. Statistically significant and non-significant bias.

    • Evaluation of the method detection limit, ССα, ССβ.