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Validity : 03rd Dec'23 to 13th 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 ...
Financial identity theft occurs when someone uses another consumer’s personal information (name, social security number, etc.) with the intent of conducting multiple transactions to commit fraud that results in substantial harm or inconvenience to the victim. ...
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 ...
Excel functions can greatly enhance your ability to perform tasks in day-to-day activities in Excel. While there are hundreds of functions available, there are 10 functions that all Excel users should know. Whether you are an office worker, a small business ow ...
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 ...
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
“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 ...