Tuesday 9th July, 2013
9:00am to 6:00pm
The instructor starts with the basics and covers advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation.
Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.
Lecture 6: Ten-Step Process for COTS Computer System Validation
Lecture 7: How to Write Requirements and Specifications
Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Lecture 9: Software Testing
Lecture 10: System Change Control
Lecture 11: Cost Reduction Without Increasing Regulatory or Business Risk
Lecture 12: Q & A
FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation
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