GAMP5 Experience Workshop Boston December 14th and 15th 2016


“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 the
course by having trainees define the business processes, execute
a system risk assessment and create requirements using their
current knowledge.
• Practical exercise of the GAMP 5 activities:
- Writing clear User Requirements
- Executing a FMEA Risk Analysis
- Translating User Requirements into a decent Design
- Describing the Configuration and Building instructions in an
unambiguous way
- Defining and executing Test Protocols and Scripts
- And Executing Changes while maintaining compliance

Download the flyer