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Artificial Intelligence tools are rapidly being adopted across FDA-regulated industries for activities such as quality review, document generation, audit preparation, complaint trending, pharmacovigilance analysis, validation support, and regulatory submission ...
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 ...
Artificial intelligence isn’t the future—it’s here now, transforming every field from healthcare to marketing. At the heart of this shift is ChatGPT, a powerful tool helping professionals write, research, and solve problems faster than ever. Understanding how ...
Everyone from the anxious beginner to the confident professional will grow from expert advice such as: Making the most of your first three minutes Reinforcing sticking points throughout your presentation Fine-tuning your eye contact, gestures and overall ...
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 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.
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 ...