21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA 2016

  • 19 Feb 2016
  • Webinar

Description

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA 2016 is a webinar that covers topics such as:

  • Develop the ability to apply 21 CFR Part 11 when implementing, and maintaining computer system validation in your organization
  • Gain an understanding of FDA’s 21 CFR Part 11 guidance document for electronic medical records training
  • Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
  • Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
  • 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 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 some of the key "pitfalls" to avoid when employing ER/ES capability
  • Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA 2016 is intended for:

  • QC/QA Managers and Analysts
  • Information Technology Analysts
  • Analytical Chemists
  • Clinical Data Managers and Scientists
  • Lab Managers
  • Compliance Managers
  • Computer System Validation Specialists
  • Automation Analysts
  • Business Stakeholders
  • GMP Training Specialists
  • Consultants

Past Events

Important

Please, check "21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance
Health & Medicine: Healthcare, Hospitals & Clinics, Medical laboratories

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions