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Computer System Validation (CSV) for FDA-Regulated Computers

Event Details

Computer System Validation (CSV) for FDA-Regulated Computers

Time: January 9, 2019 from 1pm to 2:30pm
Location: Training Doyens 26468 E Walker Dr,Aurora, Colorado
City/Town: Aurora
Website or Map: https://bit.ly/2C0iNp1
Phone: 7209961616
Event Type: online
Organized By: Training Doyens
Latest Activity: Dec 10, 2018

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Event Description

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.

The webinar will leave you with the information needed for planning, executing and documenting a computer system validation effort that meets FDA compliance standards. You will learn about the computer system validation requirements and what must be done to ensure the system remains in a validated state.

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
  • Test Planning, including Development of Scenarios, Cases and Scripts (Installation Qualification, Operational Qualification and Performance Qualification)

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
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • All FDA-regulated industries:
  • Pharmaceutical
  • Biologicals
  • Medical Device
  • Tobacco

 

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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