Introduction to Computer Validation

This course may be taught at any location.

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Level: Advanced
Lab Hours: 4.00
Lecture Hours: 4.00
Total Contact Hours: 8.00
Currently Offered
Introduction to Computer Validation - Class begins February 19, 2018

Description

This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements. Also covered are major areas subject to regulatory inspections and audit by the FDA and other international agencies. Samples of assessment tools are provided.