Medical Device Validation

An Introduction to Medical Device Validation – Part 3

This training program will be beneficial to all personnel directly involved in medical device validation, as well as new or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with validation or interact with regulatory agency inspectors to rationalize or defend validation programs will also benefit from taking this course. No experience of validation is necessary though some knowledge of processes would be beneficial.

CEU Credits: 0.1

Course Code: ELM-158

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Course Overview

Learning Objectives

Who Should Take This Course?

Module 1: The Starting Point

Introduction to Non-Product Validations

What We Will Cover?

Module 2: Non-Product Validation Program

Validation Master Plan

Risk Matrix

Individual Validation Plan

Individual Validation Plan – Validated State

Protocol Construction

Results

Test Failures and Issues

Reporting

Validation Toolbox

Module 3: Overview of Typical Protocols

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Don’t Forget About Requirements!

IQ, OQ, PQ or…?

Module 4: Introduction to Process Validation

Process Validations

Process Validation Considerations

Types of Process Validations

Validation Approach Tradeoffs

Process Validation Example – Printed Circuit Board

Installation Qualification (IQ)

Requirements & Operational Qualification (OQ)

Performance Qualification (PQ)

Potting (IQ, OQ, PQ)

Oven (IQ, OQ, PQ)

Other Validations That Need To Be Considered – Part 1

Other Validations That Need To Be Considered – Part 2

Module 5: Other Validation Considerations

Validation is a State, NOT an Event!

Intended Use

Additional Considerations

Conclusion

Final Assessment

Certification

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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