With all the news and attention that Ebola is receiving because of the recent outbreak in West Africa, it is worth it to everyone to separate some of the facts from the myths of the disease. One What is Ebola? Ebola is the cause of a viral hemorrhagic fever disease and it is an infectious […]
Recently, there has been an increased interest in the creation of products in the Life Science industry that mix traditional Pharmaceuticals and Medical Devices with creative technological tools to create interesting Medical Devices that can save lives, regenerate organs, help people walk and even track information about the habits of a patient. Sometimes these innovations […]
It is not enough anymore for a Medical Device manufacturing company to simply control what happens within the four walls of its own organization. Worldwide, global regulators are starting to require companies to control supply chain procurement, manufacturing and product distribution. According to Cerulean Associates, there were 126 FDA 483 observations of supplier control deficiencies […]
Two recent recalls due to mislabeling has called attention to the importance of proper container packaging and carton labeling of pharmaceuticals. One recall was initiated by a manufacturer of blood glucose test strips; they voluntarily conducted a Class 1 nationwide recall of their blood glucose test strips due to a labeling error that omitted the strips’ […]
Recently, the FDA admonished a Pharmaceutical organization for a telephone sales pitch about its attention deficit hyperactivity disorder drug that omitted critical risk and dosing information. Additionally, the telemarketing script allegedly didn’t mention warnings, precautions and adverse events connected with the drug, says an untitled letter released by the FDA’s Office of Prescription Drug Promotion (OPDP). […]
Recently UL EduNeering released the ComplianceWire Learner App on the Apple App Store for iPad. This App will allow users to use ComplianceWire’s functionality including CICS, quizzes, exams, forms, electronic signatures, EduFlex courses and AICC courses. Here’s more on what you need to know about the new ComplianceWire Learner App: What is the ComplianceWire Learner App? […]
Posted on 01. Aug, 2014 by Carrie McKeague.
Posted on 23. Jul, 2014 by Karl Kapp.
We all inherently know the value of communication. Organizations are continually talking about improving communications internally and with customers but, less often, organizations talk about improving communications with suppliers and other members of the supply chain. This is unfortunate because direct and indirect communications with suppliers can help to avoid problems and facilitate a closer […]
Posted on 16. Jul, 2014 by Rob Sims.
We regularly review our “course completion” statistics to get a sense of which compliance topics are critical to Compliance Officers. We are sharing these statistics as part of our new Course Watch blog articles. Clients appreciate the course statistics so they can understand some of the external training trends that may affect their learning programs. […]