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This webinar is designed to provide an overview of the problem of counterfeit drugs and suggest ways to combat it, some that have been employed for years and others that have been developed more recently. The challenge in preventing counterfeit drugs from inf ...
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...
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 ...
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Person ...
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA' s two Guidances, "510(k) Device Modifications: Deciding When to Submit a 510( ...
An external auditor is coming to your plant. Their first impression may have a major impact on your plant's future as well as your own career. How will your plant look to that auditor? Before they even set foot in the door - what your grounds and outside fa ...
In 2021, The IRS significantly changed one of the simplest in all of payroll – the W4. The W4 is used by employees to tell employers how much FIT and SIT to withhold from their paychecks. The old form simply stated marital status and number of exemptions claim ...
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 ...
Unlock the potential of AI in finance with our transformative webinar, "ChatGPT for CPAs and Finance Professionals". In this 90-minute session, delve into how ChatGPT can be your partner in navigating complex financial landscapes, from automating routine accou ...
Human error is the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role ...