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

Title
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
Authors
Keywords
Verification and validation, Computational models, Machine learning, Digital twins, Biopharmaceutical manufacturing, GMLP
Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume -, Issue -, Pages -
Publisher
Elsevier BV
Online
2021-01-23
DOI
10.1016/j.xphs.2021.01.016

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