Two day GAMP5 training
Rescop Academy is providing a GAMP 5 Experience on March 20th and 21st at Hotel Stücki in Basel, Switzerland
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*: CHF 1195,-
Early Registration Fee (prior to February 1st): CHF 1440,-
Regular Fee (from February 1st): CHF 1600,-
*Graduated after May 2017
Prices listed are excl. VAT
When will it be?
March 20th & 21st 2018
CH-4057 Basel, Switzerland