🎤  David Nettleton       |  📅  October 18, 2022   |  🕒  11 AM Eastern Time US


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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