2022 - Software Validation for the New FDA Inspections

OVERVIEW
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 invalidation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
WHY SHOULD YOU ATTEND?
Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements, analyses, and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar, you will learn the requirements in addition to functional tests that are required to produce a validated software product.
AREA COVERED
Software validation is more than testing
Requirements traceability
Risk analysis
Unit, integration, and system testing
Algorithm validation
Challenges to the software
Configuration management
WHO WILL BENEFIT?
Engineer
Engineer management
Software engineer
Programmer
Quality assurance
Regulatory
SPEAKER PROFILE
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years.
For more detail, please click on this below link:
https://bit.ly/3N0oTIs
Email: info-AT-247compliance.us
Tel: +1-661-336-9555
https://www.linkedin.com/in/whitney-jones-87357317...