Seminar on the Integration of Human Factors into Design Controls and Risk Analysis training seminars presented by Global Compliance Panel register now on FindaSeminar.com

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Seminar on the Integration of Human Factors into Design Controls and Risk Analysis  

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Global Compliance Panel   

For:

QA Managers, Risk Managers, Product Managers, Project Managers, Device Engineers

Cost:   

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Seminar Summary:

The key to integrating Human Factors is to understand the activities involved throughout the product development cycle and the corresponding design controls.  (see full course description)

 

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Training Course Syllabus:


Integration of Human Factors into Design Controls and Risk Analysis

Course "The Integration of Human Factors into Design Controls and Risk Analysis" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant´s RAC recertification upon full completion.

Overview:

Human Factors/Usability testing is now a requirement. Human Factors/Usability testing is good business and can be easily integrated into product design/development. Human Factors is at the essence of the UseFMEA and hence instrumental in being able to reduce the probability of risk, and even the severity of risk. The key to integrating Human Factors is to understand the activities involved throughout the product development cycle and the corresponding design controls. These activities will be covered with the opportunity to implement on a real world problem/device. In addition, the appropriate documentation and content will be covered so that a full picture of the integration can be understood. Differences between European and US standards will be covered as required.
Why should you attend?

Do you feel that Human Factors slows the time to market and increases costs of your products? Do you feel that Human Factors documentation is foreign and cumbersome? If you have answered yes to these two questions then you need to find out that the correct answer is quite the opposite.
Human Factors/Usability testing is now a requirement. Human Factors/Usability testing is good business and can be easily integrated into product design/development. Human Factors is at the essence of the UseFMEA and hence instrumental in being able to reduce the probability of risk, and even the severity of risk.

Areas Covered in the Session:

• Human Factors
• Risk Management
• uFMEA
• Human Factors Testing
• Design Controls
• Human Factors and Project Management
• Human Factors Documentation
• FDA and CE Mark


Agenda:

Day 1 Schedule:

Lecture 1: What is Human Factors, Design Controls, and UseFMEA (risk analysis)?
Lecture 2: Constructing a Design Controls Process
Lecture 3: Human Factors Document: Application Specification
Lecture 4: Human Factors Document: Task Analysis

Day 2 Schedule:

Lecture 1: Constructing a UseFMEA (uFMEA)
Lecture 2: How to reduce risk estimations in the uFMEA
Lecture 3: Human Factors Testing: Formative and Summative
Lecture 4: Human Factors Summary Reports

Speaker:

Virginia A. Lang
Principal and Founder, HirLan, Inc. and HirLan International SA

Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies.

Seminar Summary:

The key to integrating Human Factors is to understand the activities involved throughout the product development cycle and the corresponding design controls.  (see full course description)

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