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DSEC Events
On Demand: Reducing Time & Costs - GLP Software Validation (Aug 11)
Register for the On-Demand version of Reducing the Time and Costs Associated with GLP Software Validation in Preclinical Safety and it took place Thursday, August 11, 2011 from 11:00 AM - 12:00 PM EDT.


The webinar featured the following industry experts:

  • Shelley Gutt, Manager, Global IT Quality, Computer Systems Validation, Covance
  • Joel Sanfilippo,  Application Manger, GPRD Discovery IT, Scientific Informatics 
  • Dr. Dusty Sarazan, Vice President Strategic Planning & Chief Scientific Officer, Data Sciences International (DSI)
  • Nick Vickers, Validation and Quality Systems Engineer, Toxikon


The panel discussed the following:

* What is the number one issue of your current validation practices and how would you like to see it addressed?

* Is the current GLP validation process affecting the adoption of tools that would improve the safety assessment of drugs?

* Are new methods or processes emerging to improve the effectiveness or reduce the cost of GLP software validation? Do you know of any other area where the QA from Company X reviews and signs off on an audit or inspection of a vendor and it is used by Company Y?

* How many different GLP software validation packages have you reviewed and, at a high level, how different are they across the industry?


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