Two-day GAMP 5 Training

October 2019

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.

Course Content:

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

Program:

Day 1
Introduction
Terms & Definitions
Regulations, Guidelines & Standards
Planning Phase
Design Phase
GAMP 5 Guideline

Day 2
Summary Day 1
Build Phase
Qualification Phase
Release to Production
Operations Phase

Cases
Both days cases are included to practice the theory

Dates & Location

October 3rd & 4th 2019
Breda
The Netherlands

Investment

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