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More and more, your company is asking you to do some things with Excel spreadsheets that may leave you challenged or even overwhelmed. Maybe someone else worked on a spreadsheet, and then they moved on, and now you are in charge of that spreadsheet. That is ...
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulatio ...
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, ...
In Excel, sometimes there is a need to look up information from a table or from a different sheet, or to link the sheets together.
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 ...
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 ...
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 ...
“All software, firmware, ladder logic, must be validated” – US FDA. Verification and validation requirements have always been part of the US FDA’s GMPs. Where does 21 CFR Part 11 fit in? Pt 11 “selective enforcement”? “Add on”? Companies still struggle with th ...
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...