Course Overview

What to Expect from GAMP 5 Training

This course simplifies and streamlines the validation of computerized systems, following a risk-based approach from the ISPE GAMP® 5 Guide.

Key Highlights

• Combines theory with practical cases.
• Covers Computer System Assurance (CSA) principles.
• Focus on system quality over excessive documentation.
• Materials presented in English.

Topics Covered

• Computerized systems and their lifecycle
• SMART requirements setup and testing
• Risk assessment to reduce validation workload
• Agile development and validation deliverables
• Essential processes for system operation
• Proper documentation depth

Objectives

• Learn the phases and key activities of system validation
• Specify requirements, assess risks, and document efficiently

Target Audience

• QA, production, lab, and management professionals in pharma, medical devices, healthcare, or food industries
• Validation project contributors or reviewers

Trainer: Richard Mulders (RESCOP)

Program

Day 1

08:45     Welcome - start at 09:00
      
Module A - Introduction
      
Module B – Regulatory & User Requirements
      
Module C – Risk Management & Risk Assessment
      
Module D – Design Phase

17:00     End

Day 2

08:45     Welcome - start at 09:00
      
Module E – Development Phase
      
Module F – Verification Phase
      
Module G – Release Phase
      
Module H – Operational Phase

17:00     End

Other Details