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Site language : English - Français
Ref : 28931
Event :Project Management for Computer Systems Validation

Date :Tuesday February 26th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

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?

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

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
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

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