Computer Validation

FDA Enforcement Archived Events

A Risk-Based Approach to Software Validation

Speaker: Bikash Chatterjee, President, Pharmatech Associates
Date: April 2009

Description: Bikash Chatterjee of Pharmatech Associates presents a defensible rationale for a risk-based approach to software validation, and details how to implement this practice.

The application of risk management techniques as a compliance strategy is central to efficiently validating software in keeping with FDA’s current guidance. This webinar describes how to effectively incorporate a risk management approach to your software quality system as part of your Part 11 strategy. We’ll examine Part 11 considerations in developing and qualifying critical software, and discuss how to reconcile the disparity between FDA’s expectations for software development and industry’s practice of tailored development structures.

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