2-DAY GAMP 5 EXPERIENCE
Rescop Academy is providing a GAMP 5 Experience on October 3th and 4th At the Evaluon in Eindhoven, The Netherlands.
This two day course is designed for those who supervise, manage, audit, or perform the validation of computerised systems in a GxP environment. Upon completion of this course, participants will have a complete understanding about validation activities that need to be performed throughout the total life cycle of a given computerised system. This training course is provided in such a way that it has a highly practical approach and especially when you are involved in validation activities or with deﬁning the computerised systems validation approach these practical tips will prove to be very useful.
Following a practical case of developing a hospital transportation device, our expierenced trainers will let you experience the basics and potential pitfalls of Validation following the Good Automated Manufactering Practices (GAMP 5) Guideline.
What you would learn?
• Introduction of the case and setting a benchmark for the course by having trainees define the business processes, execute system risk assessment and create requirements using their current knowledge.
• 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 unambigious way
- Defining and executing Test Protocols and Scripts
- Executing Change while maintaining compliance
WHEN WILL IT BE?
October 3th & 4th 2017
Noord Brabantlaan 1A,
5652 LA Eindhoven, The Netherlands
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