Two-day GAMP 5 Training
Rescop Academy is providing the training ‘GAMP 5’ practitioner level on Novemer 6th & 7th in Switzerland.
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.
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 Analyse
- 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
Terms & Definitions
Regulations, Guidelines & Standards
GAMP 5 Guideline
Summary Day 1
Release to Production
Both days cases are included to practice the theory
Dates & Location
November 6th & 7th 2019
Young Professional Fee (graduated after May 2017): CHF 1245,-
Early Registration Fee (prior to October 06th): CHF 1395,-
Regular Fee (from October 06th) CHF 1595,-
Prices listed are excl. VAT