# Event Details

- **Event Name**: Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR
- **Event Start and End Date**: Tue, 20 May, 2025 at 11:00 am – Tue, 20 May, 2025 at 12:15 pm
- **Event Description**: DescriptionThis 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 write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). 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.LEARNING OBJECTIVES:Which data and systems are subject to Part 11 and Annex 11How to write a Data Privacy StatementWhat the regulations mean not just what they sayAvoid 483 and Warning LettersRequirements for local SaaS and cloud hosting Understand the current industry standard software features for security data transfer audit trails and electronic signaturesHow to use electronic signatures ensure data integrity and protect intellectual propertySOPs required for the IT infrastructureProduct features to look for when purchasing COTS softwareReduce validation resources by using easy to understand fill-in-the-blank validation documentsWHO SHOULD ATTEND:GMP GCP GLP regulatory professionalsQA/QC DepartmentsIT DepartmentsAuditorsManagers and directorsSoftware vendors hosting providersAREAS COVERED IN THE SESSION:1. What 21 CFR Part 11 means todayPurpose of Part 112 What does Part 11 mean?SOPsSystem featuresInfrastructure qualificationValidation3. Security standardsRolesUsernames and passwordsRestrictions and logs4. Data transfer standardsDeleting dataEncryption5. Audit trail standardsTypes of dataHigh risk systems6. Electronic approval standardsElectronic signaturesSingle sign-onReplacing paper with electronic forms7. Infrastructure qualificationHow to efficiently document qualifications8. ValidationSoftware validation for vendorsComputer system validation for usersFill-in-the-blank templatesChange control re-validation9. SaaS/Cloud hostingResponsibilities for software vendor and hosting providerEvaluation criteriaHosting requirements10. SOPsIT QA validationSoftware development11. Annex 11Comparison with Part 1112. EU GDPRData Privacy StatementCourse Director: DAVID NETTLETON 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” that relates 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 URL**: https://allevents.in/online/data-integrity-in-compliance-with-csa-21-cfr-part-11-saas-cloud-and-eu-gdpr-tickets/80002787881323
- **Event Categories**: workshops, virtual, trips-adventures, performances, entertainment, webinar
- **Interested Audience**: 
  - total_interested_count: 0

## Ticket Details

- **Ticket Price Range**: min: 305, max: 905, currency: USD

## Event venue details

- **city**: online
- **state**: 0
- **country**: 0
- **location**: Online
- **lat**: 0
- **long**: 0
- **full address**: Online

## Event gallery

- **Alt text**: Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR
  - **Image URL**: https://cdn2.allevents.in/thumbs/thumb6825e6bc8bb0f.jpg

## FAQs

- **Q**: When and where is Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR being held?
  - **A:** Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR takes place on Tue, 20 May, 2025 at 11:00 am to Tue, 20 May, 2025 at 12:15 pm at Online.
- **Q**: Who is organizing Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR?
  - **A:** Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR is organized by EVENTURA.US.

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