Validation and Uncertainty Calculation in Microbiological Testing

735,00 

We provide you with the necessary knowledge to carry out the design, execution, and evaluation of validations in microbiological testing. As a preliminary step, a general reflection is made on specific aspects of the microbiological laboratory that affect validation, such as culture media, reference strains, test procedures, etc. Practical examples are included, allowing you to learn how to estimate the uncertainty of the test method in order to comply with the requirements of UNE–EN ISO/IEC 17025:2017.

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COURSE PROGRAM

  1. General Concepts in Microbiology
      • Materials and Reference Strains
      • Test Methods
      • Culture Media
      • Records
  2. General Concepts of Validation
  3. Characteristics of Microbiological Measurement
  4. Statistical Concepts
      • Distributions
      • Estimators
  5. Applicable Regulations
  6. Validation Systematics
      • General Validation Criteria
      • Types of Methods in Microbiology and Validation Parameters
      • Verification of Methods Applicable to Food Product Analysis (ISO 16140-3:2021)
        • Qualitative Methods
        • Quantitative Methods
        • Confirmation Methods
      • Verification of Methods Applicable to Water Sample Analysis
  7. Introduction to Theoretical Uncertainty
      • Calculation or Estimation of Uncertainty
      • Sources of Uncertainty in Microbiology
      • Uncertainty ISO 19036:2019 – Applicable to Food Product Analysis Methods
      • Uncertainty ISO 29201:2012 – Applicable to Water Sample Analysis Methods
  8. Practical Examples for Each Section
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