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 ...
Administrative professionals sit at the center of an organization's daily operations, and even small inefficiencies in scheduling, correspondence, or documentation can ripple outward into missed deadlines and dropped details. This session offers a structured, ...
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 ...
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 ...
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 ...
In this session, you’ll discover how Excel’s AI-powered features can supercharge your productivity: Work Smarter with Copilot – Generate formulas, summaries, and insights instantly. Analyze Data in Seconds – Ask questions in plain English and get ready-to- ...
"The FDA and Cosmetic Oversight - What does that look like?" is a training session aimed at providing participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating cosmetics. The training covers various aspects, includi ...
