The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. For easy implementation, attendees will receive SOP: Validation of Commercial Off-the-Shelf Computer Systems SOP: Development and Maintenance of Test Scripts for Software and Computer Systems Checklist: Using computers in FDA regulated environments
Mississauga, Ontario 44813, Canada
Phone: 4169154458
If you'd like to ask a question or post a comment about this talk please do so below.
This seminar posting is brought to you by Biotechnology Calendar, Inc. providing access to research information and research tools for nearly 20 years. Visit our Science Market Update Blog for current science funding and market information or see our schedule of upcoming science research laboratory product shows.