Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.
Instructor
David Nettleton
FDA Compliance Specialist — 21 CFR Part 11 & Computer System Validation
What You'll Learn
About the event
About this event
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to validate software employing Artificial Intelligence (AI).
What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Topics include security standards (roles, usernames, passwords, restrictions, and logs), data transfer standards (deleting data, encryption), audit trail standards, electronic approval standards (electronic signatures, single sign-on), infrastructure qualification, SaaS/Cloud hosting responsibilities, and EU GDPR data privacy requirements.
Code: FDB3452
Curriculum
Requirements
- Working in GMP, GCP, GLP, or regulatory environments
- Involvement in QA/QC, IT, auditing, or software validation
- No prior 21 CFR Part 11 expertise required
Who Should Attend
GMP, GCP, GLP, and regulatory professionals, QA/QC Departments, IT Departments, Auditors, Managers and Directors, and Software Vendors and Hosting Providers.
Areas Covered
Meet Your Instructor
David Nettleton
FDA Compliance Specialist — 21 CFR Part 11 & Computer System Validation
David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation — Ten Easy Steps", relating to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.
Event Details
Format
Recorded Webinar
Duration
1.25 hours
Certificate
Included
Access
Lifetime
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