Day 2 - Agenda

A session at US Seminar 2013 on “Software Validation for the New FDA Inspections” from GlobalCompliancePanel

Friday 19th April, 2013

10:00am to 6:00pm

Lecture 6: Ten-Step Process for COTS Computer System Validation
Learn which documents the FDA expects to audit.
How to use the risk-based validation approach to lower costs.
How to link requirements, specifications, risk management, and testing.
Document a computer system validation project using easy to understand fill-in-the-blank templates.
Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Lecture 7: How to Write Requirements and Specifications
Workshop for writing requirements and then expanding them for specifications

Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

Lecture 9: Software Testing
Reduce testing by writing test cases that trace to elements of risk management.
How to write efficient test cases

Lecture 10: System Change Control
How to manage a validated system with minimal documentation

Lecture 11: Cost Reduction Without Increasing Regulatory or Business Risk
How to save money
How to increase quality
How to increase compliance with less documentation

Lecture 12: Q & A

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Time 10:00am6:00pm UTC

Date Fri 19th April 2013

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