Faculty: Carolyn Troiano | Code: SEM13454
This 3-Hour course strengthens your Part 11 and data integrity approach for cloud systems, delivering a practical model for documentation, shared controls, and maintaining a validated state through vendor-driven updates.
Cloud systems complicate attribution, audit trails, data movement, and shared controls — all areas inspectors examine closely. CSA Validation and Cloud Assurance helps teams understand how Part 11 applies when vendors host records, automate functions, and push updates that impact validated states. Weak documentation or misplaced assumptions about vendor responsibility often lead to significant findings. A risk-based validation approach grounded in data integrity keeps oversight sharp and defensible. CSA Validation and Cloud Assurance provides a lean, structured model for documentation, change control, and inspection readiness across SaaS and PaaS environments.
This is Module 4 of Practitioner Course "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA".
You can either sign up only for this Module here.
Carolyn Troiano brings decades of real-world validation leadership across pharma, medical devices, biotech, and other FDA-regulated sectors. She helped shape early CSV approaches, contributed to 21 CFR Part 11 discussions, and has guided global companies through complex system implementations. Her style is practical, clear, and rooted in hands-on experience with modern cloud and CSA expectations.