Data Integrity and Privacy compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

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This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, 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 11
  • How to write a Data Privacy Statement
  • What the regulations mean, not just what they say
  • Avoid 483 and Warning Letters
  • Requirements for local, SaaS, and cloud hosting
  • Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
  • How to use electronic signatures, ensure data integrity, and protect intellectual property
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Areas Covered in the Session :

  1. What 21 CFR Part 11 means today
    • Purpose of Part 11

   2. What does Part 11 mean?

    • SOPs
    • System features
    • Infrastructure qualification
    • Validation

3. Security standards

    • Roles
    • Usernames and passwords
    • Restrictions and logs

4. Data transfer standards

    • Deleting data
    • Encryption

5. Audit trail standards

    • Types of data
    • High risk systems

6. Electronic approval standards

    • Electronic signatures
    • Single sign-on
    • Replacing paper with electronic forms

7. Infrastructure qualification

    • How to efficiently document qualifications

8. Validation

    • Software validation for vendors
    • Computer system validation for users
    • Fill-in-the-blank templates
    • Change control re-validation

9. SaaS/Cloud hosting

    • Responsibilities for software vendor and hosting provider
    • Evaluation criteria
    • Hosting requirements

10. SOPs

    • IT, QA, validation
    • Software development

11. Annex 11

    • Comparison with Part 11


    • Data Privacy Statement

Who Should Attend:

  • GMP, GCP, GLP, regulatory professionals
  • QA/QC Departments
  • IT Departments
  • Auditors
  • Managers and directors
  • Software vendors, hosting providers
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