On-demand webinar: What you need to know about USP <1085>
Posted: 26 October 2020 | Charles River | No comments yet
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
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The newest USP chapter on endotoxin testing fills in the regulatory gaps that have resulted following the withdrawal of the 1987 FDA Guideline and implementation of its replacement Q&A.
In this webinar, we addressed:
- Preparatory requirements on RSE/CSE, consumables, analyst qualification, calibration, and the laboratory environment
- Method suitability for endotoxin limits, MVD, suitability testing, and common test interferences
- Routine testing for sampling, pooling, out of specification results, and retesting considerations and standard curve control
- Alternate test methods.
Related topics
Analytical techniques, Artificial Intelligence, Biopharmaceuticals, Bioprocessing, Data integrity, Endotoxin, Environmental Monitoring, Lab Automation, Manufacturing, Medical Devices, Microbiology, Proteomics, QA/QC, Research & Development (R&D), Vaccines