Course Overview

GAMP 5 Training: What to Expect

Learn a risk-based approach to validating computerized systems using the ISPE GAMP® 5 Guide, combining theory with practical cases and CSA principles.

Key Topics

• Computerized systems and their lifecycle
• SMART requirements setup and testing
• Risk assessment and workload reduction
• Agile development’s impact on validation deliverables
• Essential processes for system operation
• Proper documentation depth

Objectives

• Understand system lifecycle phases and validation activities
• Specify requirements, assess risks, and document with precision

Target Audience

• Managers, production, lab, and QA staff in (bio)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