Risk is defined as the potential hazard, harm or side effect of an activity. Almost all activities come with some or another form of risk, which needs to be mitigated or eliminated. Risk management…Continue
Started Oct 17, 2017
IntroductionHandheld devices are light-weight and compact devices that can be operated holding it in your hands. Handheld medical devices are available for medical information, used by physicians,…Continue
Started this discussion. Last reply by Arnold Brame Aug 16, 2014.
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review…Continue
Posted on January 18, 2019 at 5:16am
Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
After setting the stage for this content, we delve into the writing process beginning with the audience and how the…Continue
Posted on January 9, 2019 at 6:44am
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…Continue
Posted on January 7, 2019 at 7:28am
The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern. Part of that risk involves the intentional activity that can conflict, intrude or destroy software. The problems are taking center stage in the “healthcare software” dialogue. What issues can compromise or defeat the…Continue
Posted on January 2, 2019 at 5:58am