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This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could res ...
linical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health. Clinical trials are conducted acc ...
Process of following the procedures and processes that are agreed on during a selection audit process. It identifies nonconformances in the manufacturing process, engineering change process, invoicing process, quality process, and also the supplier/shipment pr ...
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 ...
The United States Food and Drug Administration (FDA) plays a crucial role in regulating medical devices to ensure their safety and effectiveness. In an effort to harmonize its regulatory framework with international standards, the FDA has proposed aligning its ...
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes development of a company philosophy and approach, and incorporating it into an overall computer system v ...
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of t ...
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce ...
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 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 ...