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2021 - 21 CFR Part 11, Data Integrity, and Computer System Validation
Topics/Call fo Papers
Current regulatory landscape (regulations, standards, guidance)
Basic terminology and concepts of regulated software lifecycles
Activity and documentation requirements
Change management
Cloud-hosted systems
Software-as-a-Service (SaaS)
Cybersecurity
Artificial Intelligence / Machine Learning (AI/ML)
Electronic records / electronic signatures
Audit / inspection defense
Enforcement trends
Basic terminology and concepts of regulated software lifecycles
Activity and documentation requirements
Change management
Cloud-hosted systems
Software-as-a-Service (SaaS)
Cybersecurity
Artificial Intelligence / Machine Learning (AI/ML)
Electronic records / electronic signatures
Audit / inspection defense
Enforcement trends
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- International Conference on Innovation and Management (IAM2022W)
Last modified: 2021-08-26 12:40:06