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Validity : 05th Dec'23 to 15th Dec'23
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 ...
We will delve into the five essential design principles inspired by the renowned expert, David JP Phillips. In an era where effective communication is paramount, these principles offer invaluable guidance to transform your presentations from mundane to mesmeri ...
How do you know how well your suppliers are doing? Most responses present a subjective view. It is akin to throwing darts - sometimes you are close, but most times you are "off-target". You need a tool that will provide an objective, quantitative visibility ...
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 ...
Implementing Purchasing Policies for Purchasing Professionals For existing Procurement Offices review what is working and what isn’t working in your current environment. Ask customers that your service to provide feedback or a formal customer satisfaction su ...
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...