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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 ...
Stop Feeling Silenced, Start Saying Yes (to Yourself)! Do you struggle to voice your ideas, feel constantly swamped, or like your priorities get sidelined? This energizing workshop is your key to unlocking assertive leadership. Learn how to speak clearly, set ...
Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, petrochemicals, and environmental ...
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...
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 ...
This course is designed to teach learners how to use CHATGPT for Excel, a powerful tool that can help you automate tasks, analyze data, and create reports in Excel. Throughout the course, learners will explore the features and capabilities of CHATGPT for Excel ...
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 ...
Gain easy-to-understand and practical “hands-on” knowledge of ChatGPT and Artificial Intelligence (AI) at an introductory level with a focus on significantly enhancing capabilities in Microsoft Excel. Harness the awesome power of AI to take Excel to a new lev ...
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 Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...