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.
Controller Challenges in Changing Times: New Roles as Strat…
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
How to Prepare For and Host a FDA Inspection and Respond to…
Sunshine Act Reporting - Clarification for Clinical Research
The Importance of the first 5 seconds when presenting
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Complaint Handling and Management: From Receipt to Trending
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Understanding Artificial Intelligence (AI) and the Incredib…
6-Hour Virtual Boot Camp on Microsoft Power BI
Onboarding is NOT Orientation - How to Improve the New Empl…
The Monte Carlo Simulations in Excel for Risky Investments
ChatGPT and Project Management: Leveraging AI for Project M…
Project Management for administrative professionals
Workplace Investigations 101: How to Conduct your Investiga…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Understanding Accounting for non - Accounting professionals
New Form 1099 Reporting Requirements: 2025 Compliance Update
Human Error Reduction Techniques for Floor Supervisors
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
7 Ways To Beat Burnout: Without Quitting Your Job
Treating Employees Like Adults: Discipline versus Empowerme…
Understanding EBITDA – Definition, Formula & Calculation
Ethical Terminations: Navigating Employee Exits with Legal …
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
How to Write Procedures to Avoid Human Errors
FDA Proposes Framework to Advance Credibility of AI Models
Project Management for Non-Project Managers - Scheduling yo…
Validation Statistics for Non-Statisticians
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
4-Hour Virtual Seminar on Hidden Secrets of Selling & Marke…
The Alphabet Soup: When the FMLA, ADA, COBRA, and Workers' …
Talent Management: How to Leverage AI and ChatGPT Tools for…
Offboarding with Care: Conducting Legal & Ethical Employee …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…