Two-day GAMP 5 Training
March 12th and 13th 2020
Rescop Academy is providing the training ‘GAMP 5’ practitioner level on March 12th & 13th 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
March 12th & 13th 2020
Rescop - location t.b.d.
Young Professional: € 995,-
Early Registration (up to 4 weeks prior to event): € 1125,-
Regular Fee: € 1250,-
Prices listed are excl. VAT