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

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

Online Event
Event Date: March 23, 2020 - March 23, 2020
Submission Deadline: March 23, 2020




About

This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.


Call for Papers

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



Best Deals



Credits and Sources

[1] 21 CFR Part 11 Guidance 2020 : 21 CFR Part 11 Guidance on Electronic Records and Electronic Signatures for Computer Systems Regulated by FDA


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