GAMP 5 Practitioner Training

Regulations require that computerized systems used to support or execute GxP processes, are validated for their intended use.

Duration
2 days
Course fee
€ 1125 (excl. VAT)

Short description

Validation of these computerized systems is often difficult and time-consuming, especially when you're not sure how to tackle such validation. A risk-based best practice for validation of computerized systems in a GxP environment, is described in the ISPE GAMP® 5 Guide: 'Compliant GxP Computerized Systems'.

Based on this guide, a GAMP 5 Practitioner training has been developed to help course participants understand what is expected according to the guide and the regulations when validating computerized systems. During the training, the theory from the ISPE GAMP® 5 Guide, combined with the practical experience of the trainer(s), is translated into a process-focused and risk-based approach for the validation of computer systems.

The training will continuously switch between presentation of the theory and applying this theory to a practical case. All presentation material is in English

Amongst others, the following topics will be discussed:

  • What are computerized systems
  • What is the lifecycle of a computerized system and what is the impact of being compliant
  • How do requirements follow from processes
  • How can requirements be set up in a SMART way
  • How can requirements be tested
  • How do processes help in executing a risk assessment
  • How do risk management and risk assessment help to reduce the workload of validation
  • What do different development methods, like Agile, mean to validation deliverables
  • Which environments of systems are used, why are they used, and what are they used for
  • Which processes need to be covered during Computerized System Operation
  • In what detail should documentation be developed

Objectives

  • Understanding the different phases in the lifecycle of a computerized system
  • Understanding the required activities and deliverables during validation of a computerized system
  • Learn how to specify requirements, assess risks, and document information with the right level of detail

Target group

  • Management, Production, Laboratory and QA persons working at a (bio)pharmaceutical, medical device, healthcare, or food company.
  • Personnel responsible for creating or reviewing content as part of a Validation Project.

Program

Day 1

 

Module A - Introduction

 

Module B – Regulatory & User Requirements

 

Module C – Risk Management & Risk Assessment

 

Module D – Design Phase

Day 2

 

Module E – Development Phase

 

Module F – Verification Phase

 

Module G – Release Phase

 

Module H – Operational Phase

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info@biotechtrainingfacility.nl
+31 (0)88 2830100

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