Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR 2018

Topics

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

Who should Attend

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