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:-

• What 21 CFR Part 11 means today
• Purpose of Part 11
• What does Part 11 mean? 
  • SOPs
  • System features
  • Infrastructure qualification
  • Validation
• Security standards 
  • Roles
  • Usernames and passwords
  • Restrictions and logs
• Data transfer standards 
  • Deleting data
  • Encryption
• Audit trail standards 
  • Types of data
  • High risk systems
• Electronic approval standards 
  • Electronic signatures
  • Single sign-on
  • Replacing paper with electronic forms
• Infrastructure qualification 
  • How to efficiently document qualifications
• Validation 
  • Software validation for vendors
  • Computer system validation for users
  • Fill-in-the-blank templates
  • Change control re-validation
• SaaS/Cloud hosting 
  • Responsibilities for software vendor and hosting provider
  • Evaluation criteria
  • Hosting requirements
• SOPs 
  • IT, QA, validation
  • Software development
• Annex 11 
  • Comparison with Part 11

Who Should Attend:-

• GMP, GCP, GLP, Regulatory Professionals
• QA/QC
• IT
• Auditors
• Managers and Directors
• Software Vendors, Hosting Providers