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Edwin Waldbusser


Courses

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
20 Nov This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.
Edwin Waldbusser Edwin Waldbusser
$189
21 CFR Part 11 - Compliance for Electronic Records and Signatures
03 Dec This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security
Edwin Waldbusser Edwin Waldbusser
$189
FDA Regulation of Artificial Intelligence/ Machine Learning
MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Edwin Waldbusser Edwin Waldbusser
$189
Medical Device Software Validation Meeting FDA Regulations
MP3 Download This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product
Edwin Waldbusser Edwin Waldbusser
$189
How to Prepare for and Host an FDA Inspection and Respond to 483's
MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview
Edwin Waldbusser Edwin Waldbusser
$189