21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA 2016

Key Topics

• Develop the ability to apply 21 CFR Part 11 when implementing, and maintaining computer system validation in your organization
• Gain an understanding of FDA’s 21 CFR Part 11 guidance document for electronic medical records training
• Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
• Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
• Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state
• Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capability
• Understand some of the key "pitfalls" to avoid when employing ER/ES capability
• Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge

Who should Attend

• QC/QA Managers and Analysts
• Information Technology Analysts
• Analytical Chemists
• Clinical Data Managers and Scientists
• Lab Managers
• Compliance Managers
• Computer System Validation Specialists
• Automation Analysts
• Business Stakeholders
• GMP Training Specialists
• Consultants