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March 23-26, 2026
New York City
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Chemistry Validation
Validation is designed for intended use and executed using ICH Q2 (R1/R2) aligned characteristics to support release and stability testing.
Specificity
Confirm selective measurement of the analyte to eliminate risks and to support accurate quantification, demonstrating method suitability for its intended use.
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Accuracy
Measure the trueness of the method to verify the absence of systematic error (Bias) and to confirm the reliability of reported results.
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Precision
Confirm reproducibility of results and assess random error to ensure method consistency in routine use and support data reliability and decision-making.
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Linearity
Confirm proportional response to analyte concentration to define the working range of the method and detect non-linear behavior.
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Range
Establish the usable limits of the method, ensuring that results reported within this interval are scientifically valid and reliable.
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Detection Limit (LOD)
Demonstrate the sensitivity of the analytical method, detecting very low levels of the analyte or impurity that may be critical for quality and safety.
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Quantitation Limit (LOQ)
Confirm that low-level results generated by the method are trustworthy and reproducible.
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Robustness
Ensure method reliability under normal laboratory variations and that they do not significantly affect the results.
Microbiology Validation
Microbiological method validation is designed around the intended use and is executed in accordance with pharmacopeial and regulatory requirements.
Microbial Enumeration Methods
Confirm that the method delivers accurate, consistent, and representative results of the true microbial load.
Specified Microorganisms
Confirm specific detection for the target microorganism, even in the presence of background flora, and demonstrate the absence of false-negative results.
Method Suitability & Recovery
Demonstrate the analytical procedure achieves acceptable recovery of inoculated microorganisms and ensure results are representative of true microbial content.
AET & Antimicrobial Testing
Challenge tests demonstrate that the product maintains microbiological integrity throughout use.
AET & Preservative Efficacy
Confirm sustained antimicrobial effectiveness of the preservative system and ensure compatibility with formulation and container-closure.