FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they should be conducted and establishing specifications for success.
Why You Should Attend:
All chemists involved in the development and validation of analytical methods, those who supervise them and those who review or submit their method validation reports must know about the FDA rules for method validation. Defects or absence of validation or verification of analytical methods are frequent observations of FDA application reviewers and deficiencies during FDA inspections. Learning how to minimize these problems is highly recommended.
Areas Covered in the Session :
General Information
Specificity
Accuracy
Precision
Sensitivity
Linearity
Range
Robustness
Reproducibility
Who Should Attend:
Analytical Method Development Supervisors
Analytical Method Validation Supervisors
Method Research Chemist
Analytical Chemists
QC and R&D Laboratory Supervisors
Regulatory Affairs Supervisors