The Cutting Edge of Medical Technology Content, Community & Collaboration
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Regular (unencrypted) Email and Text Messaging are effective engagement and communication tools that patients like and have the right to use.
A simple 3 step HIPAA safeguard fully protects Covered Entities from violating both HIPAA and the TCPA (Telephone Consumer Protection Act) and stymies expensive TCPA class actions. Unfortunately few take advantage of the 3 step safeguard. And the Internet is awash with mis-information that can get Covered Entities into serious…Continue
How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:
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
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