Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR is a seminar that provides strategies to reduce costs and ensure compliance with data integrity regulations, including 21 CFR Part 11, SaaS/Cloud, and EU GDPR, in computerized systems.

Key Topics

• Electronic records and electronic signatures for productivity
• Risk-based computer system validation
• Minimizing validation documentation
• Data privacy and GDPR compliance
• Change control methods for safe system evolution
• Selection of resources and management of validation projects
• Testing strategies and writing traceable test cases
• Vendor qualification and COTS software acquisition
• Inspection readiness for Part 11 and Annex 11
• Staff responsibilities including IT and QA roles
• Protection of intellectual property and electronic records
• Avoiding regulatory 483s and warning letters

Who should Attend

• QA and QC professionals
• GMP, GCP, GLP, and regulatory personnel
• Auditors
• IT staff
• Software vendors and SaaS hosting providers
• Managers and directors