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YouTubeU.S. Food and Drug Administration
GDF 2024 | D2S14 - Improving the Sterility Assurance Application to the FDA
This presentation addressed strategies for improving sterility assurance applications submitted to the FDA. requirements. Timestamps 00:36 – Admin / Organization 02:49 – Sterilizing Filtration 04:49 – Drug Master Files 06:19 – Nonsterile Powders & Bulk Bioburden Sampling 09:43 – Biological Indicators in Validation/Qualification 11:30 ...
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