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Our Phone Number +353 (0)61 514 744

Our Email info@OptimaTraining.ie

GAMP 5 Risk Management Approach

GAMP 5 Risk Management Approach

This GAMP Risk Management Approach training course is a 1 Day public programme, designed to guide participants through the latest GAMP Guidance and give them a good understanding of the current best practices for GxP compliant computerised systems in regulated environments. It will enable them to understand and interpret the key requirements for their organisation to ensure that their computerised systems are fit for their purpose and meet regulatory requirements. The GAMP 5 Risk Management Approach training course provides the attendances with guidance that is based on a risk management approach and the course will also introduce them to some risk assessment techniques.

09/09/2025

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€295.00

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Category:
Risk,Management,Strategy,Plan,Finance,Investment,Internet,Business,Technology,Concept.

Course Content:

  • Course Modules

    Module 1   : Introduction to GAMP

    Module 2   : Regulations and Regulators expectations

    Module 3   : Requirements of 21 CFR Part 11

    Module 4   : Overview of GAMP 5

    Module 5   : GAMP 5 Lifecycle

    Module 6   : Regulated Company and Supplier Activities

    Module 7   : Quality Risk Management

    Module 8   : Testing

    Module 9  : Operational Phase

    Learning Objectives

    This computerised systems validation training course covers the essential principles on how to use a risk-based approach in Computerised Systems Validation (CSV) using GAMP guidance approach.

This GAMP 5 Risk Management Approach training programme may be of interest to anyone working in regulated industries in Quality / Validation / IT / Design or related roles.

Live online webinar via GotoWebinar, instructor lead, practical hands on course.

Product Description

GAMP 5 Risk Management Approach

This GAMP Risk Management Approach training course is a 1 Day public programme, designed to guide participants through the latest GAMP Guidance and give them a good understanding of the current best practices for GxP compliant computerised systems in regulated environments. It will enable them to understand and interpret the key requirements for their organisation to ensure that their computerised systems are fit for their purpose and meet regulatory requirements. The GAMP 5 Risk Management Approach training course provides the attendances with guidance that is based on a risk management approach and the course will also introduce them to some risk assessment techniques.

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours

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