21 CFR Part 11 Guidance 2020 : 21 CFR Part 11 Guidance on Electronic Records and Electronic Signatures for Computer Systems Regulated by FDA

This webinar will cover the following key areas:

• Gain an understanding of FDA's 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
• Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems in your organization
• Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
• Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
• 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 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 gain information about trends in ER/ES validation, as industry progresses and new best practices emerge
• Understand some of the key "pitfalls" to avoid when employing ER/ES capability
• Q&A