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Introduction to Analytical Validation |
| We have distilled critical knowledge of Chromatography and Mass Spectrometry applications and instrumentation into our range of exciting and interactive Short Courses. You will learn the absolute essentials of each technique and using our unique multi-media examples and tutorial exercises you will begin to use new knowledge and ideas right away. When delivered on-site we can design the course material to suit your specific training needs and deliver to groups of up to 10. We limit numbers to 10 per course so that each delegate gets the opportunity to ask questions and fully participate in tutorial exercises |
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Course Description
This one day course covers all of the basics required to produce an analytical method development protocol, implement the validation studies and report to FDA standards. Analytical Best Practice |
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Course Content Validation Parameters:
- Selectivity
- Linearity
- Accuracy (Trueness)
- Precision
- Sensitivity
- Robustness (including experimental design and statistical analysis)
Experimental Design for Analytical Method Validation
- ANOVA, Plackett-Burman full factorial methods etc Statistical Methods and Tests for Validation
- When and how to use t-tests / f-tests to provide rigour to validation results)
- Overview of Equipment Validation
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The following topics will be considered for each of the major validation parameters:
- Definitions
- Applicability
- ICH guidelines
- Eurachem guidelines
- ISO / IUPAC guidelines
- Important Comments and Considerations
- Procedure
- Statistical Analysis (where applicable)
- Validation Protocol Statements and Reporting
- Conclusions
- Workshop / Tutorial Exercise (where applicable)
- Column maintenance
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Details and Location
Maximum Number of Delegates: 10 (20 for off-site Courses)
Location: On-Site or Off-site Duration: 1 Day |
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| To book an on-site training method validation course please click here |
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| To book an off-site training method validation course please click here |
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