Writing Effective Human Factors Validation Study Protocols for Efficient FDA Approval


Thursday, January 24, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 60 Minutes      

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In this webinar We will explore the FDA's most recent guidance publications on this topic - particularly the guidance from FDA/CDER/DMEPA, which includes an outline for protocol submissions that covers, We will follow the most recent guidance released by FDA/CDER in September 2018 as a template for this protocol in terms of essential information needed for quick and efficient reviews.
Dr. Robert North   Product Id : 502306
  Instructor : Dr. Robert North

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Overview:

Providing a clear, concise story of how you plan to conduct you human factors validation requires thorough coverage of a variety of topics.

Your study is a demonstration of how the design of the device will not cause medication error or patient/user harm when interacting with the user interface, and will be a vital piece of evidence when your submission is reviewed by the agency.

We will explore the FDA's most recent guidance publications on this topic - particularly the guidance from FDA/CDER/DMEPA, which includes an outline for protocol submissions that covers:

  • Background-user groups, use environments, user interface description including labeling, known use problems, preliminary analyses and formative evaluations
  • Analysis of Hazards and Risks-associated with use of the product in a use-related risk analysis (URRA)
  • HF Validation Testing Details-objectives, type of test, test environment, training (if any) given to participants, user groups, use scenarios to be tested and inclusion of critical tasks, definition of "successful performance", data that will be collected, method of interviewing participants regarding failures/difficulties, root cause analysis methods for understanding the user interface role in errors observed

Why should you Attend: The FDA's device and combination product human factors oversight organizations often request sponsors to provide a study protocol before conducting a final simulated or actual use study.

These validation studies are a vital component in pre-market device and combination product submissions because they provide final evidence that these device/products are devoid of medication errors or patient/user harm attributable to the product's user interface.

Writing clear and concise protocols, in language that the FDA expects, is crucial to timely reviews and avoiding additional costly time-consuming exchanges answering questions from the agency. We will follow the most recent guidance released by FDA/CDER in September 2018 as a template for this protocol in terms of essential information needed for quick and efficient reviews.

Areas Covered in the Session:
  • What FDA human factors reviewers are looking for in human factors protocol submissions
  • A typical outline for a human factors validation study protocol per the FDA guidance
  • Helpful tools to use in making points clear to FDA
  • Differences between human factors protocols and typical clinical trial protocols
  • Why submitting your protocol is important in the review process

Who Will Benefit:
  • Human Factors Managers
  • Regulatory Affairs Management
  • Risk Assessment / Management Groups
  • Quality Systems Management
  • Product Development Management
  • Human Factors Service Providers (Consulting Groups, Testing Groups, etc.)


Speaker Profile
Dr. Robert North is a regulatory-affairs focused human factors consultant specializing in the application of methods and analysis techniques for the management and control of medical device use related hazards, and usability measurement, particularly as applied to the FDA pre-market device approval process and international usability standards compliance.

He has consulted with over 200 companies regarding the implementation and documentation of medical device usability and use safety. From 2009 to 2016, he was the faculty lead of the Association for the Advancement of Medical Instrumentation's (AAMI) three day human factors short course. He is also a member of AAMI's Human Factors Standards Committee recently involved in creating and revising current human factors standards and guidances for industry.




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