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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 ...
As financial institutions, credit reporting agencies, and debt collectors increasingly rely on artificial intelligence to drive credit decisions and consumer communications, the gap between innovation and compliance has narrowed sharply. This program examines ...
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 provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...
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. Procedures for controlling electronic signatures and electronic records as described in ...
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 ...