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21:16
YouTube
U.S. Food and Drug Administration
GDF2026 - Data Integrity in ANDA Applications
Data integrity refers to the accuracy, completeness, and reliability of data that should be attributable, legible, contemporaneously recorded, original, and accurate. Through case studies, this presentation demonstrated how FDA uses a multi-disciplinary approach including inspections, software analysis tools, and bioanalytical investigations to ...
143 views
1 month ago
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