Medical Device Validation

Commissioning Qualification and Validation the Concept of CQV – Part 2

This is the second course in this program and introduces the key concepts around identifying risk, and risk analysis including risk evaluation, mitigation and communication. You should take this course after the first course on overview and risk-based impact assessment, but before the course on qualification, validation and supporting quality.

CEU Credits: 0.1

Course Code: ELM-182

Duration: 30 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Course Introduction

Course Introduction

Learning Objectives

Module 1: User Requirement Specification

URS Overview

URS Preparation Process – Part 1

URS Preparation Process – Part 2

Review Activity #1

Module 2: Risk Management

Functional Risk Assessment

Risk Identification

Risk Analysis

Risk Evaluation

Post-Mitigation Residual Risk Acceptance

Risk Communication

Risk Review

Review Activity #1

Review Activity #2

Module 3: Design Review and FAT

Design Review (DR) and Design Qualification (DQ) – Part 1

Design Review (DR) and Design Qualification (DQ) – Part 2

Design Review (DR) and Design Qualification (DQ) – Part 3

Factory Acceptance Test (FAT)

Site Acceptance Test (SAT)

Review Activity #1

Conclusion

Final Exam

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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