GAMP 5 Practitioner (2 days) - March 12th and 13th 2020, The Netherlands

GAMP 5 Practitioner (2 days) - March 12th and 13th 2020, The Netherlands

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.

 

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

March 12th & 13th 2020
Rescop - location t.b.d.
The Netherlands

Investment

Young Professional: € 995,-

Early Registration (up to 4 weeks prior to event): € 1125,-

Regular Fee: € 1250,-


Prices listed are excl. VAT

 

 

 


Register now