21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
About This Event
The Seminar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Why You Should Attend:
This seminar 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.
Who Should Attend :
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
>. Information Technology Analysts
>. Information Technology Developers and Testers
>. QC/QA Managers and Analysts
>. Clinical Data Managers and Scientists
>. Analytical Chemists
>. Laboratory Managers
>. Automation Analysts
>. Manufacturing and Supply Chain Managers and Analysts
>. Computer System Validation Specialists
>. GMP Training Specialists