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Computer System Validation for Managers

Upcoming Classes: 
Date and TimeLocationPriceBuy Now
Nov 8 2010 - Nov 9 2010Chicago950.00Add to cart
Instructor: 
Deb Bartel, MBA, CQA, PMP
Course Number: 
CS 210
Duration: 
2 days
Cost: 
$950
Continuing Education Units: 
1.6 CEUs

Course Description:

Managing people and projects is a pretty tough assignment.  Plan, manage, motivate, track, report, anticipate, fight fires...you know what's expected.  But, when the work that you're managing involves computer system validation, a whole new level of complexity is added.  Now you need to work closely and cooperatively with the quality group and document your work to a level of detail necessary to satisfy the requirements of the FDA and international regulatory agencies.

You might have heard that software validation is just a bunch of useless paperwork, or that it wreaks havoc on the project timeline.  However, this doesn't need to be the case.  Find out how utilizing a risk-based approach to computer system validation changes the old paradigm.

This course focuses on the role of Managers and Project Managers in the world of computer system validation.  We'll work with you to build the skills and understanding you need to make decisions regarding validation timelines, resources, and deliverables with confidence.

What You Get: 
  • The overall computer system validation framework and the purpose and content of each deliverable
  • Understanding of how the CSV process fits into your Software Life Cycle (SDLC or SALC)
  • Best practices for validation test execution and documentation
  • Concepts and implementation model for a risk-based approach to CSV
  • Knowledge of the components of a software quality assurance (SQA) program and auditor expectations
  • Understanding of the key FDA and international regulations and guidance regarding CSV and knowing which ones apply to your company
  • Overview of most common FDA warnings regarding software validation
Who Should Attend?: 

IT, QA, Business and Project Managers who need to:

  • Manage projects and/or departments responsible for performing CSV
  • Review or approve schedules and budgets for CSV projects
  • Review and approve CSV project deliverables
  • Understanding the FDA and international regulatory landscape around CSV
  • Understand the process of computer system validation
Materials Provided: 

Course Binder

Prerequisites: 

none