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.
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:
GMP, GCP, GLP professionals
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 206 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.
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