David Nettleton 2012 - Risk analysis for software validation-step by step instructions

This webinar teaches how to perform risk assessment in order to reduce time for software testing. As part of the 10-step risk-based approach to computer system validation, the hazard analysis technique uses fill-in-the-blank templates. Ensure compliance with QA, FDA, and clients. Learn real life examples that make application of the technique understandable in the context of any validation project. As part of the workshop, perform your own hazard analysis so you can apply what you learn to what you do.

It is recommended to take the COTS Software Validation webinar as a prerequisit.

Learning Objectives:

How to use the risk-based approach to reduce validation time and lower costs.

Avoid 483s and Warning Letters.

Step-by-step instructions for performing and documenting a hazard analysis.

Interactive real life examples.

How to document the risk assessment using a template

Reduce testing by writing test cases that trace to elements of risk management.

Perform your own hazard analysis during the workshop.

Who is the Target Audience:

IT

QA

QC

Laboratory staff

Managers

GMP, GCP, GLP professionals

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