The imperative aspect of Software Validation is the backbone of the software industry that deals with software authenticity, efficiency, and removes any invalidated bug that might risk the endurance of your software. 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.
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 the 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.
In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product, also this webinar will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.
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 the 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.
In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product, also this webinar will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.
Edwin Waldbusser
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. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
2025 EEOC & Employers: Investigating Claims of Harassment …
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Enhance Your Confidence and Leadership Presence
Managing Toxic & Other Employees Who Have Attitude Issues
Stress, Change And Team Resilience Through Humor: An Intera…
The Importance of the first 5 seconds when presenting
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Excel Power Skills: Master Functions, Formulas, and Macros …
Female to Female Hostility @Workplace: All you Need to Know
Cleaning Data without Complex Functions - A Course for Data…
The Monte Carlo Simulations in Excel for Risky Investments
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Interactive dashboards & analytics in Excel