CONFERENCE SERIES: Drug Discovery & Development
Recorded at: PepTalk: The Protein Science Week
Digital Course: Integrating Human Factors Engineering (HFE) into Drug Delivery: Get It Right the First Time
About this Product:
In this digital course, we will provide a baseline understanding of the regulatory need, common practices and real world examples of integrating Human Factors Engineering into a drug development activity. Key topics to be addressed:
- Why you should care: Regulatory expectations for the application of HFE
- What to avoid: Right and wrong ways to apply HFE to your project
- Lessons from the field: Real world examples of HFE
Site License: $1380
Agenda at a Glance:
Topic 1: Integrating Human Factors Engineering into Drug Delivery – Introduction
Topic 2: Integrating Human Factors Engineering into Drug Delivery – The "Why"
Topic 3: Integrating Human Factors Engineering into Drug Delivery – The "What"
Topic 4: Integrating Human Factors Engineering into Drug Delivery – The "How"
Topic 5: Wrap-Up and Q&A
Reade Harpham, Manager, Human Centric Design, Battelle Memorial Institute
Mr. Harpham has more than 14 years experience with a wide variety of product development projects ranging from medical devices and consumer electronics to conceptual studies for the U.S. Military and Bio-Tech markets. As manager of the Human Centric Design team, Mr. Harpham leads a multidisciplinary team of designers, behavioral scientists, human factors engineers, cognitive psychologists, design researchers, and modeling and prototyping experts. The purpose of the Human Centric Design team is to understand end user needs and translate them in to product or service opportunities. This team also designs and executes formative and summative human factors usability studies to meet FDA requirements. In his role, Mr. Harpham is actively involved in the design process from initial opportunity qualification, proposal planning and execution, through detailed design and development.
Chad Gibson, Quality Systems Manager, Health & Life Sciences, Battelle Memorial Institute
Mr. Gibson has over ten years of focused experience in the development and quality management of novel medical and in vitro diagnostic devices. Mr. Gibson is a systems engineer with a focus on regulatory, compliance, system architecture, and risk management. He is a quality system manager for staff of 75 adhering to ISO 13485, 9001, and the FDA Quality System Regulation (QSR). Currently, he holds nine US patents in the fields of drug delivery, nuclear medicine, and hospital information systems.
David Wourms, Human Factors Lead, Health & Life Sciences, Battelle Memorial Institute
Mr. Wourms has more than 20 years experience interacting with and managing applied human sciences related projects for commercial companies and government research laboratories and program offices. Mr. Wourms has supported a variety of human-in-the-loop use evaluations for medical products. As a principal investigator, he has been responsible for such activities as research protocol development; IRB study review application and coordination; data gathering and interpretation; data quality control; research assistant scheduling and oversight; and study reporting. He provides ongoing human factors support for a full spectrum medical device development service offering, specifically focused on meeting the unique, risk management centered requirements of the FDA. This support is centered on a risk-based approach to device development, and includes a thorough understanding of various ISO, AAMI, EN, and FDA standards and guidelines.
About the Conference:
CHI's PepTalk: The Protein Science Week is more than just a conference. It is a community dedicated to the evolving field of biotherapeutics and a gateway to the future of biologics. PepTalk centers around Five Protein related Pipelines: Formulation, Purification, Biotherapeutics, Expression, and Delivery. These synergistic pipelines cover biologics from upstream discovery research to downstream clinical products.