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Subscribe NewsletterAvoiding Statistical Pitfalls during Method Validation
Product Id
:
600087
Overview: The ICH guideline on Validation of Analytical Procedures (Q2R1) delineates the guidance and methodology for validation characteristics of an analytical procedure.
Like most guidelines, the terminology is vague enough to allow for several acceptable approaches and analysis. Appropriate statistical methods should be used and all relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate. A statistical approach to validation of analytical methods can minimize the amount of testing while meeting the requirements of the guideline.
Like most guidelines, the terminology is vague enough to allow for several acceptable approaches and analysis. Appropriate statistical methods should be used and all relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate. A statistical approach to validation of analytical methods can minimize the amount of testing while meeting the requirements of the guideline.
Areas Covered in the Session:
- Introduction to ICH Q2R1
- Statistical methods used during validation
- Accuracy versus Precision
- Examples and case studies
Who Will Benefit:
- Anyone responsible for, or affected by, FDA regulations on analytical method validation
- Management
- Research and Development
- Regulatory Affairs personnel
- Quality assurance/quality control personnel
- Auditors and inspectors