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This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to validate software employing Artific ...
An OSHA inspection provides a view into your organization’s safety culture. This training will share a step-by-step guide on how to strategically prepare for a safety audit before it happens, which includes newly defined rules that employers need to know. Addi ...
This training is aimed at users who have very limited knowledge of Excel. If you know what a spreadsheet is, and can navigate around and enter and edit data but want to learn more, this training is for you! It will give you a solid foundation and will equip y ...
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
AI isn’t just a buzzword - it’s a game-changer for Excel users. In this hands-on session, you’ll discover how to combine the power of Excel with ChatGPT to boost your productivity, simplify complex tasks, and unlock new levels of efficiency. Whether you’re stu ...
As AI technologies become increasingly integrated into regulated environments, regulatory agencies such as the FDA are placing greater emphasis on governance, validation, transparency, and oversight. The issuance of the FDA’s first Warning Letter associated wi ...
This webinar will examine the existing requiements for the US FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirem ...
Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities are ...
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond th ...
Auditing is a critical function in any organization, ensuring compliance, accuracy, and efficiency in various operations. While traditional auditor certification training provides a solid foundation in auditing principles, procedures, and standards, it often f ...