GAMP 5 Training

GxP Computerized Systems should be compliant with regulations. How such should be done is described in the ISPE GAMP® 5 Guide: Compliant GxP Computerized Systems. Applying to this guide is easier said than done and because of that Rescop has developed GAMP 5 training on different levels; Foundation and Practitioner. Both training levels combine the theory from the ISPE GAMP® 5 Guide with exercises to simulate the practical implementation.

The Foundation level training is suitable for people who need to be aware of what is required for the Validation of Computerized Systems. This training has a duration of 1 day.

The Practitioner level training is suitable for people who are responsible for creating or reviewing content as part of a Validation Project. This training has a duration of 2 days.

Both GAMP 5 training levels can be booked in our Open Classroom Schedule at one of our training locations, or as an In-Company training at your location.

GAMP 5 Foundation

The GAMP 5 Foundation training will include the theory from the ISPE GAMP® 5 Guide: Compliant GxP Computerized Systems, combined with the practical experience of our trainers. The foundation training is setup to teach trainees the basics of GAMP 5.

Topics regarding Computerized System Validation will be discussed, like:

  • How can requirements be setup in a SMART way?
  • How does Risk Management and Risk Assessment help to reduce the workload of validation?
  • How can requirements be tested?
  • What is the lifecycle of a Computerized system and what is the impact of being compliant?
  • Which processes need to be covered during Computerized System Operation?
  • In what detail should documentation be developed?

GAMP 5 Practitioner

The GAMP 5 Practitioner training extends the GAMP 5 Foundation training with an even more process focused approach and more in-depth content on the phases of a validation project.
The practitioner training is setup to teach trainees a process focused, risk based, approach to Computerized Systems Validation.

In addition to the Foundation training, topics regarding Process Mapping and Computer System Development will be discussed, like:

  • How do requirements follow from processes?
  • How do processes help in executing a Risk Assessment?
  • What do different development methods, like Agile, mean to validation deliverables?
  • Which environments of systems are used, why are these used, and what are these used for?

Program GAMP 5 Foundation

Day 1

  • Module A – Introduction & Regulatory Background
  • Module B – Planning Phase
  • Module C – Design & Build Phase
  • Module D – Test & Install Phase
  • Module E – Run & Operate Phase

Program GAMP 5 Practitioner

Day 1

  • Module A – Introduction
  • Module B – Regulatory & User Requirements
  • Module C – Risk Management & Risk Assessment
  • Module D – Design Phase

Day 2

  • Module E – Build Phase
  • Module F – Verification Phase
  • Module G – Release Phase
  • Module H – Operational Phase