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Langue du site : Français - English
Réf : 28931
Evènement :Project Management for Computer Systems Validation

Date :Mardi 26 Février 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.

Objectives

Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance. The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market.

This 2-hr training session will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Program

  • Basics of Project Management
  • Basics of Computer Systems Validation
  • Project Planning for a Computer Systems Validation Project
  • Common Pitfalls and How to Avoid them
  • What is FDA's most current thinking related to computers and electronic records?
  • What are the inspection trends?
  • What are most frequent recent citations for Part11?
  • What are the most frequent deviations for computer system validation?
  • How important is risk based Part11 compliance?

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

Project Management for Computer Systems Validation Management
computer systems validation training, project management for csv, fda regulations for computer systems, 21 cfr 11 compliance training, project management for 21 cfr part 11 compliance
Professionnels, Project Managers IT Management Business Process Owners Quality Managers Quality Engineers GxP Consultants Pharmaceutical Compliance Officers Biotech Professionals Medical Device Professionals Anyone involved with the FDA
10 -- --
English

Divers

Pour plus d'informations sur Project Management for Computer Systems Validation, veuillez contacter ComplianceOnline

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