Medical Device Validation

An Introduction to Medical Device Validation – Part 2

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-157

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

Product Life Cycle Validation – Part 1

Product Life Cycle Validation – Part 2

The Four Validation Flavors

Risk Considerations

Software Considerations

Module 2: Product Validations

Product Validations – Non-Comprehensive List

Product Validations - Closer Look at Efficacy and Usability

Product Validation Plan

Product Validation Plan – The Outline

Activities

Responsibilities

Strategies, Tools and Methods

Test Entry / Exit Criteria

How Issues are Reported and Dispositioned

Resources Required

Reporting

Module 3: Protocol Construction

Protocol Construction – Regulatory

Protocol Construction – Expectations Part 1

Protocol Construction – Expectations Part 2

Results

Test Failures and Issues

Test Failures and Issues – Example 1

Test Failures and Issues – Example 2

Reporting – Part 1

Reporting – Part 2

Individuals Performing Validation Work

Dates Validation Performed

Identification of Inputs (Materials) Used

Identification of Equipment Used

Objective Evidence of Meeting Expected Results

Disposition of all Test Failures and Safety Assessment

Conclusions (Safe, Effective, Compliant)

Module 4: Device Product Validation Example

Setting the Scene

Enzyme Analysis Systems Validations – Safety and Efficacy Part 1

Enzyme Analysis Systems Validations – Safety and Efficacy Part 2

Enzyme Analysis Systems Validations – Packaging and Transportation

Enzyme Analysis Systems Validations – Packaging and Transportation

Programming Software

Device Software

Reporting Software

Conclusion

Final Assessment

Certification

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