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
