Faculty: Edwin Waldbusser
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.
Session 1: Design Control
Session 2: Hazard Analysis
Session 3: Human Factors / Usability Analysis
Session 1: Software
Who Should Attend: