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Developing a Strategic Approach to FDA Compliance for Computer System Validation

Event Details

Developing a Strategic Approach to FDA Compliance for Computer System Validation

Time: November 30, 2017 from 1pm to 2:30pm
Location: 26468 E Walker Dr, Aurora, Colorado 80016-6104
Street: 26468 E Walker Dr, Aurora, Colorado 80016-6104
City/Town: Aurora
Website or Map:
Phone: 7209961616
Event Type: online, webinar
Organized By: Training Doyens
Latest Activity: Oct 31, 2017

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Event Description


You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient.  The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV).


An FDA inspection or audit is something to take very seriously, and it’s important to have all computer systems that are regulated by FDA fully validated.  In this FDA Compliance training, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them in a validated state.  This will provide you with a level of certainty that you will be able to respond to FDA questions and provide the documentation necessary to defend your approach and body of work.


  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way


  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists

All FDA-regulated industries:

  • Pharmaceutical
  • Biologicals
  • Medical Device
  • Tobacco


  • Learn about industry best practices related to compliance and computer system validation
  • Learn about strategies for reducing the cost and complexity of compliance with FDA regulations


For more detail please click on this below link:



Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

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