GC Validation On-Site Course (Part No: CS-IE-GC-16)

1 day course for up to 10 analysts

These courses have been designed for those who are developing and validating analytical methods within a regulated laboratory.
These courses can help to overcome the steep learning curves associated with working in a regulated environment and can help the experienced analyst to develop and validate methods more quickly and concisely.
The courses can be custom designed for your particular situation (often based on your existing validation SOP’s) and delivered by experts in the field of regulatory compliance within a number of industries assuring you top quality training every time.

Alternatively – if you require a general update on validation of analytical methods we have off the shelf courses that contain all of the same topic information listed below.

Overview of the method development strategy with a view to rapid and concise validation
- Choosing correct injection and detection techniques
- Column Choice and Optimisation
- Optimising the Separation with Temperature Programming or Gradient Elution etc
- Method Transfer Strategies
- Update on Current Regulatory Requirements including:
* FDA / MCA / ICH Guidelines
* DWI Guidelines
* NAMAS Guidelines
* ISO and GLP Requirements
* Environmental Quality Standards
* Extrapolation of Guidelines or Requirements into Actual Validation Experiments

Industry Specific Requirements
- Pharmaceutical and Biosciences:
* Stability
* Degradation
* Assay
* Related Substance etc
- Environmental:
* Assay
* Limit Tests
* Residue Analysis
* Drinking Water Analysis
* Performance Testing
- Validation Topics include:
* Linearity
* Accuracy
* Precision
* Bias
* Specificity
* Repeatability
* Reproducibility
* Robustness Testing
* Performance Testing
* Inter and Intra-Laboratory Studies