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Site language : English - Français
Ref : 28130
Event :Computer System Validation

Date :Tuesday November 06th, 2018

Location :Training Doyens 26468 E Walker Dr,Aurora, Colorado
80016-6104 Aurora, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

 

OVERVIEW

According to the FDA requirements all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Computer system validation is more than testing. It is testing plus design control and configuration management.
How to plan and conduct a risk based validation will be explained. Overall risk for computer system is a combination of software complexity and product risk as determined by probability, severity and detectability rankings. Also involved in the risk evaluation is the requirement for purchased software supplier qualification. In this computer system validation training you’ll learn how to integrate risk based supplier evaluation into the computer system validation process. 
Validation Master plan and System Validation Plans will be explained.
Testing, based on risk, includes requirements validation and IQ, OQ and PQ. A procedure for each level of complexity and risk will be described.

WHY SHOULD YOU ATTEND

Validation of computer system software is completely different than validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission.

AREAS COVERED

  • Computer system validation strategy
  • Requirements documentation
  • Complexity and risk analysis
  • Creating a detailed test plan based on risk
  • Supplier qualification
  • IQ, OQ and PQ

LEARNING OBJECTIVES                                      

  • Computer system validation life cycle models and Validation Plan contents
  • How to determine the complexity category of your system based on GAMP 5 principles
  • Guidelines on how to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure
  • What level of testing is necessary based on software complexity and risk
  • Integrating software supplier evaluation into the computer system validation in pharmaceutical industry
  • What requirements documentation is necessary
  • How to plan and conduct IQ, OQ and PQ

WHO WILL BENEFIT

  • IT Staff
  • Computer System Users
  • Quality Assurance
  • Regulatory
  • System Vendors

 

For more detail please click on this below link:

https://bit.ly/2Pl2Ei9

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

 

 

 

 


Location

Map and directions
Conference address :
Training Doyens 26468 E Walker Dr,Aurora, Colorado
80016-6104 Aurora
United States
tel : +1 720-996-1616
Map and directions

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Details

Computer System Validation Pharmacy
computer system validation in pharmaceutical industry, gxp systems validation process, gxp compliance checklist
Professionals
20 1 --
English

Other

For more information on Computer System Validation, plsase contactr Training Doyens

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