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.
Live Webinars
By: Edwin Waldbusser
Oct. 18, 2024
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is essential to FDA-regulated companies, and how its conformance to Part 11 differs from having good IT security.
Procedures for contr…
Industry: FDA Compliance Duration: 60 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
By: Edwin Waldbusser
Nov. 19, 2024
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.
FDA has regulated medical software by means of regulations and guidance for years, how…
Industry: FDA Compliance Duration: 60 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
By: Edwin Waldbusser
Dec. 6, 2024
How to Prepare For and Host a FDA Inspection and Respond to 483's
In this webinar, you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations s…
Industry: FDA Compliance Duration: 60 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
Chronicles
By: Edwin Waldbusser
Recorded Session
21 CFR Part 11 Conformance for Medical Devices
This Webinar will explain what 21 CFR Part 11 is? Why it is important for FDA regulated companies? and how conformance to Part 11 differs from just having good IT security? Procedures for controll…
Industry: FDA Compliance Duration: 90 Minutes
By: Edwin Waldbusser
Recorded Session
Software Validation for the New FDA Inspections
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…
Industry: Medical Devices Duration: 60 Minutes
By: Edwin Waldbusser
Recorded Session
Medical Device Hazard analysis following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program be implemented.
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Industry: Medical Devices Duration: 60 Minutes
By: Edwin Waldbusser
Recorded Session
Human Factors Usability Studies Following ISO 62366 and FDA Guidance
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the …
Industry: FDA Compliance Duration: 60 Minutes