Two-day GAMP 5 Training
Rescop Academy is providing the training ‘GAMP 5’ practitioner level on October 3rd & 4th in The Nederlands.
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
October 3rd & 4th 2019
Young Professional Fee (graduated after May 2017): € 995,-
Early Registration Fee (prior to September 4th): € 995,-
Regular Fee (from September 4th) € 1125,-
Prices listed are excl. VAT