Reduce costs for compliance with data integrity: 22 CFR Part 11, SaaS/Cloud, EU GDPR is a course that provides strategies to significantly reduce costs and streamline compliance with computer system validation in regulated environments, focusing on Part 11 and Annex 11 requirements, data security, and FDA standards.
Topics
- Reducing costs, usually by two-thirds, for compliance with electronic records
- How to use electronic records and electronic signatures to maximize productivity
- What is expected in Part 11 and Annex 11 inspections so you are prepared
- Avoiding 483 and Warning Letters
- Responsibilities and specific duties of your staff including IT and QA
- Responsibilities and liabilities when using SaaS/cloud
- How HIPAA expands Part 11 compliance
- How to perform risk-based Computer System Validation using fill-in-the-blank templates
- How to select resources and manage validation projects
- "Right size" change control methods that allows quick and safe system evolution
- Minimize validation documentation to reduce costs without increasing regulatory or business risk
- How to reduce testing time and write test cases that trace to elements of risk management
- How to comply with the requirements for data privacy
- How to buy COTS software and qualify vendors
- Protect intellectual property and keep electronic records safe
Reduce costs for compliance with data integrity: 22 CFR Part 11, SaaS/Cloud, EU GDPR brings together
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, SaaS hosting providers
