GAMP® 5 Experience Training
This course is based on the quote of Confucius. 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.
The day will start with the introduction of the case and setting a benchmark for the course by having trainees create Requirements Specifications and execute Risk Assessment using their current knowledge.
|"I hear and I forget
I see and I remember
I do and I understand"
- Confucius -
GAMP® 5 Experience Workshop
After that the theory of each subject is introduced by the trainer followed by a practical exercise of the GAMP® 5 activities, like: writing clear User Requirements, executing FMEA Risk Analyses, 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 Change while maintaining compliance.
This training is available for individuals at one of our training facilities in Eindhoven (Rescop main office) or Breda (NAC, Rat Verlegh Stadium).
This training is also available for groups at our training facility in Breda (NAC, Rat Verlegh Stadium), or at your own location.