Faculty: Carolyn Troiano | Code: SEM13452
This 3-Hour course delivers a practical CSA playbook for SaaS and PaaS validation — how to trust vendors smartly, verify what matters, and build documentation strong enough to stand up to FDA scrutiny.
Cloud platforms shift constantly, and vendor-driven updates reshape controls faster than CSV methods can react. CSA Validation and Cloud Assurance helps teams evaluate supplier evidence, interpret SOC reports, and determine what must be verified internally. Many organizations struggle to separate vendor responsibility from their own, leading to documentation gaps, weak oversight, and avoidable audit findings. With Part 11 expectations extending into digital workflows, clarity becomes essential. CSA Validation and Cloud Assurance provides a practical structure that blends vendor trust with verifiable assurance, ensuring SaaS and PaaS systems remain compliant without slowing innovation or over-documenting routine functions.
This is Module 2 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.