21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA 2016 is a webinar that covers topics such as:
- 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
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA 2016 is intended for:
- 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