What is Computerized Testing Systems | GxP Compliance Testing 2018

What topics are covered by the course?

Day 1 Schedule

Lecture 1:
Introduction and Background

Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
Introduction to Testing
GaMP5 Key Concepts
Risk Management Methodology
Lecture 2:
Leveraging the Suppliers' Work

Supplier Assessment
Leveraging Supplier Testing
Determining Appropriate Test Evidence
What to do if the supplier does not meet testing requirements
Lecture 3:
Test Planning & Management

Types of Testing
Test Policies & Level of Testing
Non-Linear S/W Development (e.g. Agile)
Test Plan or Strategy
Test Specifications, Cases & Scripts
Testing Environments
Lecture 4:
Test Execution & System Handover

Test Pre-Requisites
Manual Test Execution
Automated Test Execution
Test Results Recording & Reviewing
Test Reporting & System Handover
Day 2 Schedule

Lecture 5:
Operational Phase Testing

Change Control
Test Environments
Change Implementation / Approval / Rollback
Lecture 6:
Data Migration Testing

Data Migration Principles
Manual Data Migration
Automated Data Migration
Data Migration Verification
Change Control for Data Migration
Lecture 7:
Case Studies - Part 1

Testing Configurable IT Systems
Testing Spreadsheets and End-User Developed Applications
Testing of Cloud Applications
Testing Analytical Instruments
Lecture 8:
Case Studies - Part 2

Testing of Infrastructure & Interfaces
Testing Process Control Systems
Testing Packaged Systems
Testing Systems Applying Process Analytical Technology
Quiz: Jeopardy!!!!

Testing GxP Computerized Systems

Who should attend?

VP of IT
Director of IT
Quality Managers
Project Managers (for CSV / IT)
Validation Specialists
Database Administrators
System Administrators
Directors / Senior Directors of Discovery
Directors / Senior Directors of Development
Directors / Senior Directors of Commercialization
Document Managers
Training Managers

What will I be able to do on completion?

Medical Device
Radiological Health
Blood Products
Companion Animals

How will I be assessed?

This seminar provides attendees with hands-on guidance on the testing of computerized and software systems that impact patient safety, product quality and data integrity. It will identify the testing that should be performed and the associated level of documentation. The areas covered are:
How does testing fit into GaMP5 lifecycle
Risk based methodology for testing
How do I leverage supplier testing
What should I test?
How much testing is enough?
How should I conduct the tests
How should I document my testing
How do I maintain the testing integrity of my system
Testing related 483s and Warning Letters
Case Studies


Guide Price: $1,295.00

Delivery: Classroom
Category: Health & Medical »
Duration: 2 Days
Qualification: 100

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