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Who should attend Human Factors and Predicate Combination Products
Quality Assurance, Regulatory Affairs, Device Engineers, Device Manufacturers, Pharma / Medical Device
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Seminar Summary:

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. (see full course description)

 
 
 

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Training Course Syllabus:


Human Factors and Predicate Combination Products

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring.

Learning Objectives:

Are you familiar with the role of Human Factors with respect to combination products and the FDA requirements?
Are you current on the FDA´s current perspectives on Human Factors?
Human Factors has become increasingly important to the FDAs approval of medical devices. It is a part of the design and development of the device and the collateral information, e.g., labeling, IFUs, and training. Incorporating Human Factors into the device development process can get a product to market faster and cost less. Hence, this seminar will cover all of the current and future Human Factors FDA requirements and show how to not increase costs or time.

Areas Covered:

Overview of Human Factors and the FDA perspective
Human Factors Methods and Device Product Life Cycle
Human Factors and Risk Analysis & Management
Human Factors: What Devices Require Human Factors Evaluation and Validation?
Human Factors and Combination Products
Human Factors and Combination Products Submitted in an ANDA

DAY 01(8:30 AM - 4:30 PM)

Registration Process - (8:30 am till 8:45 am)
Lecture 1: Overview of Human Factors and the FDA perspective
Lecture 2: Human Factors Methods and Device Product Life Cycle
Lecture 3: Human Factors and Risk Analysis & Management
Lecture 4: Human Factors: What Devices Require Human Factors Evaluation and Validation?

DAY 02(8:30 AM - 4:30 PM)

Lecture 1: Human Factors and Combination Products (Part 1)
Lecture 2: Human Factors and Combination Products (Part 2)
Lecture 3: Human Factors and Combination Products Submitted in an ANDA (Part 1)
Lecture 4: Human Factors and Combination Products Submitted in an ANDA (Part 2)

Seminar Summary:

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. (see full course description)

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