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

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

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Overview

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.

Areas Covered in the Session :

• 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

Speaker Profile :

Carolyn Troiano is Keynote Spe aker at ComplianceKey.She has more than 30 years of experience during which she worked directly, or as a consultant, for many top-tier pharmaceutical, medical device and biological companies in the US and Europe. She was responsible for computer system validation compliance activities across all GxP functions at a major pharmaceutical company. She developed computer system validation programs and strategies and was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation.

Contact Info :

Compliance Key

https://www.compliancekey.us/

Email :[email protected]

Phone : +1 717-208-8666