LIVE WEBINAR
Data Integrity: What Exactly Is Required for 21 CFR Part 11,
SaaS/Cloud, EU GDPR
- July 16, 2026
- 11 AM Eastern Time US
- 3 PM GMT
- 75 Minutes
- Streaming Available
- 90 Minutes
- Certificate of Completion
Designed for professionals responsible for data integrity, system validation, or ensuring compliant use of electronic records across regulated digital environments.
ABOUT THE COURSE
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.
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 AI and 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
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
- 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
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