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Jun 2016


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Good Documentation Practices to Support FDA Computer System Validation - By Compliance Global Inc.

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Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Why Should You Attend:

You should attend this webinar training on computer system validation regulated by FDA, if you are responsible for planning, executing or managing the validation of a system. This is true whether using a "wet" or ink-based signature, or an electronic signature. It is also true whether maintaining paper-based or electronic records. Different requirements pertain to each type of signature or record, and there is a specific set of best practices that need to be followed for either type.

Areas Covered in this Webinar:

  • Learn the requirements for documenting efforts related to systems governed by FDA
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable

Learning Objectives:

  • Get an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements
  • Understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs

Who Will Benefit:

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

Speaker Profile:

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
For more detail please click on this below link:

Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510


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