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.
Discover how Emotional Intelligence turns AI from a technic…
AI in B2B Marketing: What Your Compliance Team Needs to Know
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Effective And Defensible Documentation Of Employee Problems…
Stress, Change And Team Resilience Through Humor: An Intera…
2026 EEOC & Employers: Investigating Claims of Harassment …
Be a Better Leader: Dealing with your Inner Control Freak, …
Burnout to Fired-up : Recognizing and Preventing Burnout in…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Project Management For Administrative Professionals
HR Metrics and Analytics 2026- Update on Strategic Planning…
The Emotionally Intelligent Manager: Thriving Under Pressure
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
Launch Your Career: The Ultimate Guide for Emerging Profess…
GROUPBY and PIVOTBY functions. Pivot table killers?
ChatGPT and Project Management: Leveraging AI for Project M…
Stop Letting That Difficult Person Ruin Your Day: Effective…
Recruiting Top Talent in a Digital Era
Copilot and HR: An Introduction for HR Professionals
The Importance of the first 5 seconds when presenting
How to Write Procedures to Avoid Human Errors
Microsoft Excel - Data Validation Techniques
Using Claude in Excel for Productivity, Automation & Data A…
AI for Excel Professionals: Enhancing Productivity with Cha…
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
Human Factors Usability Studies Following ISO 62366 and FDA…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Implementing an Effective Succession Plan to Identify, Deve…
ChatGPT for HR - Build HR Policy Framework and Strategy
Boost Financial Analysis with Claude in Excel
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…