Day 2 – Agenda

A session at 2-day In-person Seminar on “Software Validation for the New FDA Inspections” at Bangalore

Tuesday 9th July, 2013

9:00am to 6:00pm (HMT)

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

About the speaker

This person is speaking at this event.
David Nettleton

FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation

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Time 9:00am6:00pm HMT

Date Tue 9th July 2013

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