Seminar on the 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.

GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost

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.

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

Who Will Benefit:

QA Managers
Risk Managers
Product Managers
Project Managers
Device Engineers

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

Location: Washington, DC Date: May 26th & 27th, 2016 Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON

Price: $1,295.00 (Seminar for One Delegate)

Until April 20, Early Bird Price: 895.00 from April 21 to May 24, Regular Price: $1,095.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: [email protected]

Website: http://www.globalcompliancepanel.com/

Registration Link - http://bit.ly/design-controls-risk-analysis

Speaker and Presenter Information

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. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients� FDA 510(k) and CE mark applications.

Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.