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Top Risks To Human Factors Submissions And How To Avoid Them

November 17, 2020 @ 11:00 am - 12:30 pm

$10 – $25

Program Manager:

Eri Hirumi, Program Chairperson for OCRA

 

Speaker: 

Jessie Huisinga, PhD

 

For the last 2 years, FDA has presented the statistics that only 4-11% of human factors (HF) submissions are acceptable upon first submission. This means 89-96% of HF submissions are not acceptable the first time they are submitted to FDA. When HF data are required for a regulatory submission, regulatory affairs professionals who desire a successful HF submission need to understand and be involved in certain critical aspects of the HF program and HF activities to ensure regulatory success. In this webinar, we will use case studies and activities to cover:

 

  • The top HF deficiencies in submissions cited by FDA
  • Impacts these deficiencies have on regulatory submissions
  • How to monitor HF activities or programs and identify risks to the regulatory submission
  • How to determine readiness for HF submission
  • Impacts of the coronavirus pandemic on regulatory HF programs and tips for handling the impacts

Cost:

  • OCRA Members: $25
  • Non-Members: $100, includes 1-year OCRA membership
  • Government and Student Members: $10, with student/government ID
  • Non-Member Government and Student Rate: $45, includes 1-year OCRA membership

Speaker Bios

Jessie Huisinga, PhD, Senior Consultant, Human Factors Engineering, Agilis Consulting Group LLC

 

Dr. Jessie Huisinga is a Senior Human Factors Consultant and Manager of Human Factors Engineering with Agilis Consulting Group, LLC and an expert in assessing human performance with extensive experience working with individuals with neurological impairments. She has a background in Biomedical Engineering and Biomechanics, with specialized training in Neurology to evaluate movement patterns and task performance in persons with performance limitations. She has experience assessing a diverse spectrum of home and professional use medical products as well as conducting simulated, in-home, and remote use usability studies.

 

 

OCRA Registration Instructions:

 

Last day to register:  Nov 16, 2020.

It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.

 

Certificates of attendance will be emailed within a day of the event. OCRA’s non-profit Federal Tax ID# 33-0630455

 

Cancellation Deadline:

 

For a refund, please email your cancellation request to OCRA Program Chair ([email protected]) by NOV 16, 2020.

 

If you have any questions or require additional information, email OCRA Program Chair ([email protected]).

Details

Date:
November 17, 2020
Time:
11:00 am - 12:30 pm
Cost:
$10 – $25
Website:
https://ocra-dg.org/event/top-risks-to-human-factors-submissions-and-how-to-avoid-them/

Venue

Instrument Kit03