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System Development Life Cycle Approach to Computer System Validation and FDA Compliance

Event Details

System Development Life Cycle Approach to Computer System Validation and FDA Compliance

Time: December 12, 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: https://goo.gl/FLvpME
Phone: 7209961616
Event Type: online, webinar
Organized By: Training Doyens
Latest Activity: Nov 13, 2017

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Event Description

OVERVIEW

This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.  You will learn about what must be done to ensure the system remains in a validated state.  In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.

WHY SHOULD YOU ATTEND

This FDA Compliance training will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating 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. 

AREAS COVERED

  • 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

WHO WILL BENEFIT

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers

All FDA-regulated industries:

  • Pharmaceutical
  • Biologicals
  • Medical Device
  • Tobacco

LEARNING OBJECTIVES

  • To understand how to create, revise and maintain documentation that is FDA-regulated.
  • To understand the many deliverables required to complete a computer system validation effort.
  • To understand industry best practices.
  • To understand and avoid potential pitfalls.

 

For more detail please click on this below link:

https://goo.gl/FLvpME

 

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

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