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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.

4.8(0 reviews)
3 hours
Carolyn Troiano

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

What You'll Learn

Cloud architecture explained for GxP teams (SaaS vs. PaaS vs. IaaS)
Vendor audit, oversight, and leveraging SOC 2 and ISO 27001 evidence
Supplier testing and assurance mapping for SaaS validation
Documentation expectations for SaaS/PaaS validation under CSA
Intake of vendor updates and change notifications
Config vs. code — the critical distinction under CSA

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

Cloud Architecture Explained — SaaS vs. PaaS vs. IaaS
20 min
Vendor Audit, Oversight, and Leveraging SOC 2/ISO 27001
20 min
Supplier Testing and Assurance Mapping
20 min

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

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.

45+ Years CSV Experience21 CFR Part 11 Co-DeveloperIndependent FDA Consultant
Quantity
1

Recording – 1 Viewer

$498.00
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Certificate of completion

Event Details

Format

Recorded Webinar

Duration

3 hours

Certificate

Included

Access

Lifetime

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