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In Good Manufacturing Practice (GMP) environments, human error is a persistent challenge that can lead to deviations, batch failures, regulatory non-compliance, and even product recalls. Studies show that over 70% of GMP deviations are attributed to human erro ...
This webinar will discuss the best practices for the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
When difficult employee behavior is not addressed properly, other employees become resentful, they lose respect for your organization’s leaders, and they start modelling the difficult employee’s behavior. Employee morale decreases and your organization’s resul ...
Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reac ...
An external auditor is coming to your plant. Their first impression may have a major impact on your plant's future as well as your own career. How will your plant look to that auditor? Before they even set foot in the door - what your grounds and outside fa ...
HR professionals talk to a lot of people every single day. And not all conversations are easy or pleasant. From personal issues to professionalism and even personal hygiene, HR regularly engages in difficult conversations. It is important that these delicate t ...
Control charts are based on the distribution of data expected in a laboratory, the Gaussian distribution of occurrences. There are well defined probabilities for the data. Guidelines for good or unacceptable behaviour are well known. The most common of these a ...
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 ...
ChatGPT 101: A Comprehensive Beginner’s Guide is a step-by-step, interactive seminar created for HR professionals who are new to AI and want to start with ChatGPT. Unlike broad AI overviews, this session focuses on hands-on application—showing you exactly how ...