Two-day GAMP 5 Training

Rescop Academy is providing the training ‘GAMP 5’ practitioner level on June 21st & 22nd 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:

Summary Day 1
Case: Processes & System Risks
Case: High Level Requirements Terms & Definitions Regulations, Guidelines & Standards Requirements Specification
Case: SMART Requirements, Risk Assessment
Case: Functional Risk Assessment, GAMP 5 Guideline
Case: Design, Installation & Instructions

Summary Day 2
Case: Build, Waterfall vs Agile, Qualification Phase
Case: Test Protocols, Test Execution
Case: Verification, Release to Production, Procedural Controls
Case: Operations

Dates & Location

June 21st & 22nd 2018
Utrecht or surrounding areas
The Netherlands

Investment

Young Professional Fee (graduated after May 2016): € 895,-
Early Registration Fee (prior to June 1st): € 1125,-
Regular Fee (from June 1st) € 1250,-
Prices listed are excl. VAT