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.
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Strategic Interviewing & Selection: Getting the Right Talen…
Conflict Resolution in a Remote Workplace
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Workplace Investigations 101: How to Conduct your Investiga…
Cleanroom, Microbiology and Sterility Assurance Practices f…
5 Key Components of Good Manufacturing Practices to obtain …
Successfully Negotiating the Labor Agreement
Understanding the incredible uses and fallbacks of ChatGPT
Wage And Hour Laws: Ensuring Compliance With The Fair Labor…
How to Manage Conflict in the Workplace
Neutralizing Harassment - How to Promote the Proactive Pers…
Human Error Reduction Techniques for Floor Supervisors
Hybrid Workplace: 10 Best Practices to Manage Your Team’s P…
Using Better Managerial Decision Making - to get great resu…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Using Stay Interviews To Improve Employee Retention & Engag…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Using High-Performance Coaching for Managers to Address Per…
FDA Technology Modernization Action Plan (TMAP) and Impact …
FDA Audit Best Practices - Do's and Don'ts
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
Become an excellent Critical Thinker to greatly improve you…
Learn the Do's and Don'ts of Opening Business Bank Accounts
Project Management for HR, Administrative Professionals, an…
Writing Effective 483 and Warning Letter Responses
Dealing With Difficult People In Life & Work