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 ...
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 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 ...
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 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 ...
Medication safety depends on reliable processes across the entire medication-use pathway. This webinar examines common medication errors and the system factors that contribute to them in clinical practice. The session covers prescribing errors, wrong drug or d ...
The pharmaceutical industry is undergoing a significant digital transformation. Advances in artificial intelligence, digital health, data analytics, and personalized medicine are creating new approaches to drug discovery, clinical research, safety monitoring, ...
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including wh ...
Pharmacovigilance plays a central role in monitoring the safety of medicines and identifying potential risks during real-world use. This webinar introduces the US pharmacovigilance landscape with a practical focus on adverse event reporting and the processes u ...
