Course description:

This course is intended to enable the learners to create correct and proper lists of clinical hazards (CHL) and harms (HAL).  The CHL and HAL are reusable lists that support risk management of all the products that a company, or a site produces.  CHL and HAL are effective labor-saving tools.

Intended Audience:

RM #102 is intended for R&D, Quality, and Clinical/Medical staff.  It is especially important that members of clinical/medical staff receive this training as they provide the competence for the distinction of hazards and harms, and the linkage between the hazards and harms.

Objective:

The introductory course offers knowledge on the following topics:

• Vocabulary of risk management
• What CHL and HAL are
• The connection between CHL & HAL
• The utility and benefits of CHL and HAL
• How CHL & HAL relate to ISO 14971
• Hazard taxonomy
• Risk estimation
• Challenges with creating a CHL
• Maintenance of a CHL
• How to create a CHL <workshop>
• How to distinguish harms
• How to classify harm severities
• How to think about P2
• The challenges with creating a HAL
• Independence of P1 and P2
• Two methods to create a HAL
• How to create a HAL <workshop>
• Maintenance of a HAL
• Tips and wisdom

Upon completion, participants should:

1.       Understand what CHL and HAL are, why are they important and what is their utility
2.       Understand how the CHL & HAL support compliance to ISO 14971
3.       Understand how the CHL & HAL can save time and labor in risk management
4.       Become proficient in distinguishing hazards and harms
5.       Understand risk estimation and risk reduction
6.       Know how to classify harms in 5 severity classes
7.       Know how to create a CHL and a HAL
8.       Recognize and be prepared for challenges with creating a CHL and a HAL
9.       Understand the importance of CHL and HAL maintenance and how to maintain them

Duration: 4:00 hours

Language of instruction: English

Means of delivery: In-person, and online via Zoom

CEU: ASQ and CSQE certified professionals can receive CEUs. Ask for a certificate of attendance.

About the Instructor

Award winning, international educator, consultant, and author

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups.  He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices.  In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide.  Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering.  At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results.  Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling book: Safety Risk Management for Medical Devices, published by Elsevier publishing.