“I hear and I forget; I see and I remember;
I do and I understand”
- Confucius -
This course is based on the above quote of Confucius.
Why you should attend?
Following a practical case of developing a hospital transportation
device, our experienced trainers will let you experience the
basics and potential pitfalls of Validation following the Good
Automated Manufacturing Practices (GAMP 5) guideline.
What you will learn?
• Introduction of the case and setting a benchmark for thecourse
by having trainees define the business processes, execute system
risk assessment and create requirements using their current
• Practical exercise of the GAMP 5 activities:
- Writing clear User Requirements
- Executing FMEA Risk Analyses
- Translating User Requirements into a decent Design
- Describing the Configuration and Building instructions in an
- Defining and executing Test Protocols and Scripts
- And Executing Change while maintaining compliance
Who should attend?
• (Key) Users of Computerized Systems
• Process / System Owners
• Quality Assurance Officers / Managers
• IT Application & Infra Specialist / Managers
• Higher (line) Management
• Any other function that needs to understand
When it will be?
9th and 10th Feb 2017
Where it will be?
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