GAMP 5 & CSA Practical training

Short description
Objectives
Target group
Program
Questions?

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

Duration: 2 days
Course fee: € 1695 (excl. VAT)

Short description

What can you expect from this GAMP 5 training?

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' and 'GAMP 5 Good Practice Guide ‘Enabling Innovation’.

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 based on principles of Computer System Assurance (CSA).

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
How do you ensure the right focus (quality of the system versus documentation) (CSA)
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

Who should follow this GAMP 5 course?

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.

Richard Mulders (RESCOP)

Trainer

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