Events

Trends of 2020 related to 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Sys-tems Regulated by FDA

Created by Training Doyens (See other events)
  • Apr 2, 2020 from 15:00 to 16:00
  • Location: Webinar
  • Latest Activity: Oct 12, 2020
Pharmaceuticals and other FDA regulated industries need to ensure that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with FDA 21 CFR Part 11. Our upcoming webinar discusses how to plan, execute or manage the implementation of any system governed by FDA regulations that uses ER/ES capability using cost-effective methods, techniques and tools.The webinar covers the following key areas:• Gain an understanding of FDA’s 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document• 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• 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 capabilityLEARNING OBJECTIVESGain an understanding of FDA’s 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance documentDevelop the ability to apply 21 CFR Part 11 regulations when implementing, validating and maintaining computer systems in your organizationUnderstand the best practices for maintaining a computer system with ER/ES capability in a validated stateDiscuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriatelyLearn 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 capabilityUnderstand 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 stateLearn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emergeUnderstand some of the key “pitfalls” to avoid when employing ER/ES capabilityQ&AWHO WILL BENEFITInformation Technology AnalystsQC/QA ManagersQC/QA AnalystsClinical Data ManagersClinical Data ScientistsAnalytical ChemistsCompliance ManagersLaboratory ManagersAutomation AnalystsComputer System Validation SpecialistsGMP Training SpecialistsUse Promo Code SPRS20 and get flat 20% discount on all purchases.To Register (or) for more details please click on this below link:http://bit.ly/36YpyUCEmail: support@trainingdoyens.comToll Free: +1-888-300-8494Tel: +1-720-996-1616Fax: +1-888-909-1882Check out our popular webinars:1. 3 Hour Excel Automation Boot Camp: Pivot Tables, Top 10 Functions & Formulas, Basics of Macros and VBA - http://bit.ly/39hfVTa2. Improving Employee Engagement through Structured Mentoring - http://bit.ly/2QvVk6I
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