Validating Cloud & Digital GxP Systems Using a CSV/CSA Approach

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Validating Cloud & Digital GxP Systems Using a CSV/CSA Approach

Clear Validation Ownership and Inspection-Ready Decisions for Cloud Systems

Cloud systems supporting GxP operations require clear validation ownership, especially when vendor responsibilities, data integrity expectations, and inspection scrutiny intersect in real-world implementations. This session structures validation approaches across cloud architectures, aligning risk-based decisions, supplier evidence, and system lifecycle activities into a consistent, inspection-ready validation model.

Designed for professionals responsible for validation decisions, system oversight, or ensuring data integrity across cloud-based or hybrid GxP environments.

How This Session Is Structured

The session moves from identifying GxP-relevant systems and defining ownership boundaries, into applying risk-based validation thinking across SDLC activities. It then addresses supplier documentation, vendor qualification, and automated testing considerations, before concluding with inspection positioning and maintaining validation assurance in frequently changing cloud environments.

Key Areas Covered

Identifying GxP-relevant cloud and SaaS systems using risk-based qualification tools
Applying CSV and CSA principles across modern system architectures
Defining shared responsibility and validation ownership in cloud environments
Evaluating supplier documentation and SOC 2 evidence for compliance support
Integrating SDLC and GAMP®5 considerations into cloud validation strategies
Meeting data integrity and 21 CFR Part 11 expectations in multi-tenant systems
Maintaining validated state with automated testing and frequent system updates
Presenting validation rationale during FDA inspections

Course Director

Carolyn Troiano

Carolyn Troiano brings over four decades of experience in computer system validation, including direct involvement in developing 21 CFR Part 11 alongside FDA and industry partners. Her work across large-scale IT implementations and compliance programs positions her to address cloud validation ownership, supplier reliance, and risk-based decision-making in modern GxP environments.

What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

A confirmation email outlines onboarding details and next steps
Access credentials are shared in advance so you are prepared before the session
Handouts (where applicable) are provided ahead of time
The training is delivered live via Webex with interactive participation and Q&A
Certificates of completion are issued following the session
For live + recording access, post-session availability is provided through TalkFDA
Event support remains available for any access or logistics assistance

Access is provided in a structured and professionally supported format.

A confirmation email outlines onboarding and next steps
The complete session recording is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Recording includes the full presentation and instructor-led discussion
Certificates of completion are issued upon course completion
Support remains available for any technical or access assistance

For Teams Seeking Deeper Implementation Support

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

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