2020 - IT Systems Validation for FDA Regulated Industries

GxP/GMP Systems
FDA Regulatory Oversight over IT systems validation
Regulations: 21 CFR 11, Annex 11, GAMP 5
System Development Life Cycle (SDLC) approach to validation
Documenting IT Systems validation efforts
Policies and procedures needed to support the validation process
FDA audit preparedness as far as IT systems validation is concerned
Risk based approach to validation
Clinical trial related IT systems validation