2020 - 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

Computer System Validation (CSV)
System Development Life Cycle (SDLC) Methodology
Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
Data Integrity (DI)
Validation Strategy, Planning and Execution
System Risk Assessment
GAMP 5 “V” Model and Software Categorization
21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
Security, Access, Change Control and Audit Trail
Criteria required to ensure data is created and maintained with integrity through its life cycle
Policies and Procedures to support CSV and DI assurance
Training and Organizational Change Management
Current FDA Trends in Compliance and Enforcement
Industry Best Practices and Common Pitfalls
Q&A