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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 ...
In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct t ...
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact ...
It has become critical for employers to understanding how to calculate tax for employees in 2 or more states. Plus what state laws for payroll need to be followed when employing employees in more than one state. This webinar will give the participant a bette ...
Effective technical writing is a cornerstone of successful FDA submissions, serving as a critical bridge between scientific data and regulatory review. Regulatory agencies like the FDA rely on clear, concise, and well-structured documentation to evaluate the s ...
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. Human errors start at the design stage. From p ...
This Webinar will outline the basics of design control for medical devices and the device part of a combination product. Failure to develop these products under design control may result in a product that is not suited for the intended market or failure of app ...
This session introduces the exciting possibilities of combining Microsoft Excel with the free version of ChatGPT. Whether you're an Excel novice or a seasoned spreadsheet wrangler, you'll discover how AI can help you work smarter—not harder. We’ll explore how ...
1099s report payments made to non-employee service providers, as well as payments to suppliers and other entities you do business with. Think of your own organization: Can you name all the types of service providers you use? Do you know which payments are repo ...
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDL ...