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Computer System Validation (CSV) for FDA-Regulated Computers

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Wednesday, January 9, 2019  1:00 PM
End:   Wednesday, January 9, 2019  2:30 PM

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Event Features: Health / Wellness

Neighborhood: Avenue of the Arts


       



https://bit.ly/2EbH50X


OVERVIEW FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with FDA system validation rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology.
WHY SHOULD YOU ATTEND
This webinar 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
• Functional Requirements Specification (FRS) to include detailed needs that are described in a specific and unique way
• System Design Specification (SDS) that details how the functional requirements will be delivered
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 for Computer System Validation.
• To understand and avoid potential pitfalls.
WHO WILL BENEFIT
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
For more detail please click on this below link:
https://bit.ly/2SBwikz


Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

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