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.
Transform Data into Insights: A Beginners Guide to Excel Pi…
Leadership: Strategic Planning and Decision Making
Onboarding Best Practices for 2025: Proven Strategies to Po…
Seeking Truth: Detecting Truth, Lies and Deception in a Wor…
Managing Difficult Employee Conversations
Copilot and HR: An Introduction for HR Professionals
How to Document Employee Discussions and Why it is Important
Dealing With Difficult People In Life & Work
How to Write Effective Audit Observations: The Principles f…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
FDA Compliance And Laboratory Computer System Validation
4-Hour Virtual Seminar on Transformational Leadership - The…
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Negotiating Skills For Professional Results - Winning Strat…
Building Thriving Teams: Proactive Strategies for Managers …
Designing Employee Experiences to Build a Culture of Compli…
Empowering Conflict Resolution: Letting Go to Gain Control
Navigating Alcohol and Drug Addiction Protections Under the…
President Trumps Executive Orders And What They Mean to Emp…
The Anti-Kickback Statute: 2025 - Year in Review
FDA Technology Modernization Action Plan (TMAP) and Impact …
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
Workplace Investigations 101: How to Conduct your Investiga…
50+ new Excel features so far this decade
FDA Regulation of Artificial Intelligence/ Machine Learning
From Challenges to Compliance: Understanding Dietary Supple…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
The Importance of the first 5 seconds when presenting
Why EBITDA Doesn't Spell Cash Flow and What Does
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…
Impact Assessments For Supplier Change Notices
The Monte Carlo Simulations in Excel for Risky Investments
Understanding the incredible uses and fallbacks of ChatGPT
California Meal and Rest Breaks: What You Don't Know Can Co…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Onboarding is NOT Orientation - How to Improve the New Empl…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
6-Hour Virtual Seminar on Learning the Highlights of Excel …