INTERACTIVE
WEBINAR

 
Call-in teleconferencing 
 
Video demonstrations included in the presentation
 
 
 
610-399-4897
 

 

 

 
  


  

Risk-Based Approach to Computer & Software Validation

 
May 19, 2010 WEBINAR
1 - 2:30 pm EST
 
Registration fee below for one dial-in, one person.  Call for discounts to register more than one person. 
 


This webinar explains exactly how to perform and document validation of a commercial off-the-shelf (COTS) software system. The validation approach uses the well-known 10-step risk-based fill-in-the-blank templates. Efficient techniques are taught so that documentation is more manageable and understandable. You will learn how to increase productivity and decrease project time and costs, usually by two-thirds.

Learning Objectives:
  • How to use the risk-based validation approach to lower costs.
  • Write and link together requirements, specifications, risk assessment, and test cases.
  • Based on: "Risk-Based Software Validation – Ten Easy Steps"(Davis Horwood International and PDA - www.pda.org, 2006).
  • Create the documents required by the FDA and avoid 483s and Warning Letters.
  • Decrease resources and reduce costs from vendor-supplied services.
  • Reduce testing effort and make testing meaningful.
  • Increase individual productivity and overall system productivity while minimizing re-validation costs.
  • Make validation documents easy to understand and update for future re-validation projects.
  • Use risk management to enhance quality and reduce validation project time.
  • Significantly reduce software costs and implementation times.

The Target Audience:  

  • Users of computer systems
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • Executives  
 
FEE: $365 for one dial-in, one person.
Call to register more than one person.
 

Instructor: David Nettleton

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 192 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is“Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.


 
REGISTER NOW!  CLICK HERE!
610-399-4897
 
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