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Verification and Validation of Computational Models Used in Biopharmaceutical Manufacturing: Potential Application of the ASME Verification and Validation 40 Standard and FDA Proposed AI/ML Model Life Cycle Management Framework

Gautier Bideault, Anthony Scaccia, Thomas Zahel, Robert W. Landertinger, Chathuri Daluwatte

2021Journal of Pharmaceutical Sciences18 citationsDOI

Topics & Concepts

BiopharmaceuticalCredibilityComputer scienceVariety (cybernetics)Work (physics)SoftwareSet (abstract data type)Computational modelSystems engineeringEngineeringArtificial intelligenceMechanical engineeringBiologyProgramming languageGeneticsLawPolitical scienceManufacturing Process and OptimizationAdvanced Statistical Process Monitoring
Verification and Validation of Computational Models Used in Biopharmaceutical Manufacturing: Potential Application of the ASME Verification and Validation 40 Standard and FDA Proposed AI/ML Model Life Cycle Management Framework | Litcius