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Ruggedness and Robustness in Nitrosamine Analysis from Pharmaceutical Elastomers
Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Ank Reumer, Senior Study Director, Quantitative Methods Team at Nelson Labs This
webinar will outline elements to consider in the ruggedness and robustness of methods of analysis for nitrosamine from elastomers used in pharma. It will
present a review of sources of nitrosamines in elastomers, together with how these have changed over time. It will give a chronology of the concerns and r…
Established Conditions in Analytical Procedure: Overview, Regulatory Examples
Full title: Established Conditions in Analytical Procedure: Overview, Regulatory Examples and an FDA Laboratory Study Established conditions (ECs) are
manufacturing and control elements considered necessary to assure product quality (e.g., ECs in manufacturing process) and to help assure method
performance (e.g., ECs in analytical procedures). ECs in analytical procedures help to maintain reliable results that can ensure the efficient product control …
