Two day GAMP5 training
Rescop Academy is providing a GAMP 5 Experience on March 15th and 16th at The Golden Tulip Keyser in Breda, 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
Young Professional Fee (graduated after May 2017): € 995,-
Early Registration Fee (prior to February 1st): € 1125,-
Regular Fee (from February 1st) € 1250,-
Prices listed are excl. VAT
When will it be?
March 15th & 16th 2018
Golden Tulip Keyser Breda
4811HL Breda, The Netherlands