2021 - 21 CFR Part 11, Data Integrity, and Computer System Validation

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