1SO 14971:2019

ISO 14971:2019: Different Perspectives of a Risk Management Program

In this course we will discuss the different viewpoints. This is not discussed in the standard, but these things are typically done so to give you a true perspective on Risk Management, it’s important to discuss these. It’s important to recognize that risk NEEDS to be viewed through different lenses to ensure a successful program. If we just do a single FMEA, for example, we are likely not considering all aspects that should be considered.

CEU Credits: 0.1

Course Code: ELM-338

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Program Introduction

Overview

Learning Objectives

Who Will Benefit from This Training?

Materials Used

Program Overview

Course Introduction

Course Introduction

Learning Objectives

Setting the Scene

Setting the Scene

Design FMEA – Part 1

Design FMEA – Part 2

Design FMEA – Part 3

Design FMEA – Part 4

Useability Engineering and Use FMEA – Part 1

Useability Engineering and Use FMEA – Part 2

Useability Engineering and Use FMEA – Part 3

Software

IEC 62304

IEC 60601-01(14)

SOUP

Cybersecurity

Cybersecurity – Part 1

Cybersecurity – Part 2

Wireless Risk Analysis

PFMEA

Conclusion

Final Exam

Certification

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.