Data Integrity – In compliance with CSV/CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR

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Data Integrity – In compliance with CSV/CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR

Data integrity decisions across cloud and local systems require clear alignment between system features, SOPs, validation scope, and regulatory expectations before implementation begins. This session structures how regulatory requirements translate into system controls, documentation practices, and validation approaches across SaaS, cloud, and on-premise environments.

Designed for professionals responsible for data integrity, system validation, or ensuring compliant use of electronic records across regulated digital environments.

How This Session Is Structured

The session progresses through how regulatory expectations map to system design, SOPs, infrastructure qualification, and validation. It then addresses security, audit trails, and electronic signatures, before covering SaaS responsibilities, vendor evaluation, and data privacy considerations to ensure alignment across global regulatory frameworks.

Key Areas Covered

Interpreting 21 CFR Part 11 requirements for modern digital systems
Mapping SOPs, system features, infrastructure, and validation responsibilities
Defining security controls including access, roles, and system logs
Applying audit trail and electronic signature expectations
Evaluating SaaS and cloud vendor responsibilities and hosting requirements
Aligning validation approaches for vendors and system users
Addressing Annex 11 and EU GDPR data privacy requirements
Establishing data transfer, encryption, and retention controls

Course Director

David Nettleton

David Nettleton brings extensive experience in Part 11 compliance, computer system validation, and software lifecycle management across regulated industries. His work in gap analysis, vendor audits, and system validation projects positions him to clarify how data integrity requirements translate into system features, SOPs, and validation decisions across cloud and SaaS 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
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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