Computer System Validation Basics

Date:        No date scheduled.
Location:  Not selected.
Cost:        Member $225 / Non-Member $300

Breakfast available at 8:00 a.m.
Workshop will end at approximately 4:00 p.m. each day.

The cost of registration includes a continental breakfast, lunch and snacks, the course manual, and an attendance certificate.

This two-day, interactive workshop is offered for those individuals with little or no experience in the conduct of computer validation activities. This workshop will provide basic information and practical application for conducting/auditing computer validation in a GxP environment. 

Topics covered include:

	Software Development Lifecycle Overview
	Planning/Conducting/Documenting the validation process
	Testing Phases and Associated outputs
	Overview of FDA 21 CFR Part11 and HIPAA
	Warning Letters and 483 citations for computer validation
	Validation documentation for Laboratory Instrument/Application Systems