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.
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
Dealing With Difficult People In Life & Work
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Copilot and HR: An Introduction for HR Professionals
Beat Workplace Burnout: 10 Proven Techniques to Manage Your…
Workplace Investigations Uncovered: Best Practices and Stra…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Keys to Captivating an Audience: Informing and Inspiring t…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Understanding Artificial Intelligence (AI) & using Chat GPT
Transform Data into Insights: A Beginners Guide to Excel Pi…
Empowering Conflict Resolution: Letting Go to Gain Control
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Bootcamp for New Managers and Supervisors: Develop These Es…
Project Management for administrative professionals
Negotiating Skills For Professional Results - Winning Strat…
How to Write Effective Audit Observations: The Principles f…
How to Use ChatGPT to Write Employee Evaluations
Power BI - Getting Started Building Reports and Dashboards
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
Onboarding is NOT Orientation - How to Improve the New Empl…
How to Conduct Exit Interviews - Implementing and Enhancing…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
2025 EEOC & Employers: Investigating Claims of Harassment …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…