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Analytical Method Validation Training

1 Day

The training provides comprehensive coverage of the practical design, running of and troubleshooting of a typical analytical validation

This one day course provides the foundation on which to build a practical approach to validating an analytical method. We work through each of the main validation parameters, looking at how these are applied in a practical environment to allow the design of test samples and set meaningful limits.

Although ICH Q2 guidelines form the key reference, this course focuses primarily on the practical application of these principles, to enable the design of laboratory experiments, with a focus primarily on chromatographic and spectroscopic analysis. It is presented in an accessible format aimed at laboratory personnel looking to implement, better understand or improve their validations. The material is heavily workshop based, using real analytical data to allow delegates to gain experience in the review and troubleshooting of many common causes of validation failure.

 
  • Overview of the validation process
  • The validation protocol
  • Specificity
  • Accuracy and recovery
  • Linearity and range
  • Sensitivity
  • Precision
  • Robustness

The Method Validation Process

Regulations

  • ICH Guidelines
  • Validation Protocol
  • Nested Design

Specificity

Accuracy (Trueness) and Recovery

Linearity and Range

Precision

  • Repeatability
  • Intermediate Precision
  • Reproducibility

Sensitivity

  • Limit of Detection (LOD)
  • Limit of Quantitation (LOQ)

Robustness

The following topics will be considered for each of the major validation parameters

  • ICH Guidelines
  • Definitions
  • Applicability
  • Typical Experimental Approaches
  • Relationship with Method Development
  • Workshop exercises

This course is for analysts who require a better understanding of the practical aspects of designing and running a validation in support of a typical instrument analytical method.

It is also of benefit to those in a quality assurance or project management role who have to review validation protocols and reports.

Good knowledge of typical instrumental analysis and associated data.

HPLC Method Development

GC Method Development

Calibration and Quantitation

Forced Degradation

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