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Faculty: Edwin Waldbusser

  • Date: 3/23/2021 12:00 AM - 3/23/2021 04:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


US FDA believes that a device cannot be considered safe and effective unless the design has followed a rigorously controlled step by step process. This virtual seminar will teach you how to set up and maintain a process that will pass FDA inspection. We will discuss both hardware and software. The newer requirements pertaining to Hazard Analysis and Human Factors will be explained and you will be shown how to integrate these into the Design Control program.

Why You Should Attend:

This virtual seminar is the perfect go-to course if you are looking for a wholesome understanding Design control program. This session will answer the important and confusing question of when design control begins in a development process. The session will explain the difference between pre-release and post-release change control. Edwin will further explain the design history file and will discuss a contents checklist. He will also explain the interrelationship between ongoing risk analysis and the design process. 

The session will explain in detail the process of conducting a hazard analysis. It will explain confusing terms like “hazard,” hazardous situation,” “harm,” “causative event,” “ALARP,” “risk index” and “residual risk”. We will also explain the process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies. We will discuss various types and methods of human factors analysis. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.

Finally, this course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. We will discuss what must be done but will not discuss methods to execute necessary testing.

Seminar Agenda:

Session 1: Design Control

  • Reasons for design control
  • When design control begins
  • Elements of a design control program
  • How risk managements fits into design control
  • How human factors fits into design control
  • Change control
  • Understanding validation consists of more than testing
  • Design history file

Session 2: Hazard Analysis

  • Explanation of confusing terms
  • Step-by-step explanation of hazard analysis process using a template
  • Integration of human factors studies into the hazard analysis
  • How to deal with residual risk?
  • How to integrate human factors studies into the hazard analysis
  • How to integrate hazard analysis into the design program

Session 3: Human Factors / Usability Analysis

  • User error vs. use error
  • Human factors studies for design process
  • Device risk analysis
  • Validation of the effectiveness of human factors studies

Session 1: Software

  • Software Validation more than Testing
  • Requirements Traceability
  • Risk Analysis
  • Unit,Integration and System Testing
  • Algorithm Validation
  • Challenges to the Software
  • Configuration Management

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Medical Device Software Developers
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Marketing Departments
  • Documentation Departments
  • Purchasing Departments