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In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDL ...
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks. Participants will learn systematic approaches to identify root causes, develop effe ...
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 ...
Pivot Tables have been a mainstay of the Excel program for two decades, and yet they remain a daunting and little understood tool. If you are a daily user of Excel, eventually you will be faced with the challenge of data summaries and analysis. The 1st l ...
Excel is a powerful tool, but mastering it can be challenging. ChatGPT can act as your AI assistant, guiding you through complex formulas, data analysis, and automation without extensive technical knowledge.
This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...
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 ...
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 ...
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 describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulat ...