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
Topics & Concepts
BiopharmaceuticalCredibilityComputer scienceVariety (cybernetics)Work (physics)SoftwareSet (abstract data type)Computational modelSystems engineeringEngineeringArtificial intelligenceMechanical engineeringBiologyProgramming languageGeneticsLawPolitical scienceManufacturing Process and OptimizationAdvanced Statistical Process Monitoring