RFC Implementation Strategy For Endotoxin Testing

Presented by

Lindsey Silva and Evelyn Der, at Genentech, Kevin L. Williams at bioMérieux and Allen L. Burgenson at Lonza

About this talk

Presented by Lindsey Silva, Ph.D. Director, Microbiology in Analytical Sciences at Genentech, Evelyn Der, Senior QC Scientist at Genentech, Kevin L. Williams, Endotoxin Sr Scientist at bioMérieux and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions Lonza Walkersville, USA The webinar will provide insight into the regulatory landscape for recombinant Factor C (rFC) implementation as a sustainable endotoxin test method. A range of considerations for method validation activities to ensure health authority acceptance will be covered in the webinar including rFC method validation requirements as an alternative non-pharmacopeial method, rFC method implementation considerations for pharmaceutical water and product testing, and rFC method transfer strategy for QC network adoption.
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