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Faculty: David Nettleton

  • Date: 10/18/2022 11:00 AM - 10/18/2022 12:15 PM
  • Time zone: Eastern Time (US/Canada) Online Event


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

Who Should Attend:

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

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