Name: Regulation 808: Operation of Analytical Methods for Residues of Pharmacologically Active Substances Used in Food-Producing Animals
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Regulation 808: Operation of Analytical Methods for Residues of Pharmacologically Active Substances Used in Food-Producing Animals

Course Program

Scope of Application
Definitions
Test Methods
Interpretation of Results
Performance Criteria and Other Requirements for Analytical Methods
Statistical Concepts
Validation. Performance Characteristics
Test Uncertainty
Quality Control
Extension of the Validated Scope (Test Category)
Sampling and Handling of Official Samples

INTRODUCTION

- General
- Definitions

TEST METHODS
- General
- Performance Criteria
  - Screening Methods
  - Confirmation Methods

1. 1. - General Requirements
    - General Performance Criteria for Confirmation Methods
    - Requirements Applicable to Chromatographic Separation
    - Specific Performance Criteria for Mass Spectrometry
    - Specific Performance Criteria for Determination of an Analyte by Liquid Chromatography with Detection Techniques Other Than Mass Spectrometry

VALIDATION
- Performance Characteristics That Must Be Determined for Analytical Methods
- Trueness, Repeatability, and Intra-laboratory Reproducibility
  - Conventional Validation

1. 1. - Trueness Using Certified Reference Material
    - Trueness Using Spiked Samples
    - Repeatability
    - Intra-laboratory Reproducibility

- Validation Using Alternative Models
- Other Validation Approaches
- Selectivity/Specificity
- Robustness
- Stability
- Decision Limit for Confirmation (CCα)
- Detection Capability of Screening (CCβ)
- Calibration Curves
- Absolute Recovery
- Relative Matrix Effect

QUALITY CONTROL
- General
- Screening Phase
- Confirmation Phase

EXTENSION OF THE VALIDATED SCOPE OF A PREVIOUSLY VALIDATED METHOD
- General
- Extensions Related to the Concentration Range
- Extensions Related to Additional Substances
- Extensions Related to Matrices or Species

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