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.
Why This Training Matters
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.Course Content
- Cloud architecture explained (simple, GxP-focused)
- SaaS vs PaaS vs IaaS responsibilities
- Vendor audit and oversight
- Leveraging SOC 2, ISO 27001, CSA STAR, wiz.io?
- Supplier testing → assurance mapping
- Documentation expectations for SaaS/PaaS validation
- Intake of vendor updates + change notifications
- Config vs code (critical distinction under CSA)
Speaker
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.Who Should Attend
- Quality Assurance (QA)
- Quality Control (QC)
- Regulatory Affairs (RA)
- Validation / Computerized System Validation (CSV)
- Information Technology / Information Systems (IT/IS)
- Cloud Engineering and Automation Teams
- Manufacturing and Production Leadership
- Data Governance and Data Integrity Teams
- R&D and Digital Development Teams
- Lab Informatics and LIMS/ELN Administrators
- Compliance, Audit, and Inspection Readiness Teams
- Design and Software Development Engineers
