The CSA Playbook for SaaS, PaaS & Modern Digital Platforms — 3-Hour Course
A 3-hour CSA playbook for SaaS and PaaS validation — learn to evaluate vendor evidence, interpret SOC reports, separate responsibility, and build FDA-defensible documentation.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
Cloud platforms shift constantly, and vendor-driven updates reshape controls faster than CSV methods can react. 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.
Many organizations struggle to separate vendor responsibility from their own, leading to documentation gaps, weak oversight, and avoidable audit findings. This course provides a practical structure that blends vendor trust with verifiable assurance, ensuring SaaS and PaaS systems remain compliant without slowing innovation.
This is Module 2 of the Practitioner Course "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA."
Code: SEM13452
Curriculum
Requirements
- QA, Validation, IT, Cloud Engineering, and Regulatory Affairs professionals
- Applicable to data governance teams, manufacturing leadership, and compliance teams
Meet Your Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training on CSV, 21 CFR Part 11, Data Integrity, and many other compliance topics of interest to the life science industries.
Event Details
Format
Recorded Webinar
Duration
3 hours
Certificate
Included
Access
Lifetime
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