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.
6-Hour Virtual Boot Camp on Microsoft Power BI
2-Hour Virtual Seminar on Empowering Presentations with Pow…
Motivated to Stay: Effective and Best Practice Retention Me…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
The Anti-Kickback Statute: Enforcement and Recent Updates
Mindful Communication:The Key to Meaningful Conversations i…
Managing Toxic & Other Employees Who Have Attitude Issues
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Employee Handbooks: 2025 Critical Issues
Accounting For Non Accountants : Debit, Credits And Financi…
ChatGPT and Project Management: Leveraging AI for Project M…
50+ new Excel features so far this decade
2025 EEOC & Employers: Investigating Claims of Harassment …
Why EBITDA Doesn't Spell Cash Flow and What Does?
Retaining Talent in the Age of Employee Shortages
Succession Planning Simplified: Fast-track Your Future Lead…
Workplace Compliance in 2025: New Laws, Big Changes, and Wh…
How to Write Contracts for Procurement Professionals
Leverage AI & ChatGPT for Talent Acquisition: Best Practice…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
Leadership: Strategic Planning and Decision Making