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. [...]
With the advent of cloud-based computing, also known as virtually hosted solutions or software as a service (SaaS), following standardized and industry accepted practices become increasingly important. Every day, more and more organizations are hosting sensitive records via third party organizations. Validation of systems is an important part of adhering to regulations to ensure a [...]
Organizations both large and small are increasingly relying on third parties to help with everything from design, to development, to assembly and many processes in between. In order to properly realize the benefits of third parties, the risks must be carefully controlled. A robust program to manage risks works for both organizations when the program [...]
Posted on 19. Jun, 2014 by Karl Kapp.
Dietary supplements seem to be more popular than ever and the FDA is closely watching the industry. Episodes like the one with USPlabs’ product OxyElite Pro which appears to have been connected to dozens of serious incidents of liver injury, are causing scrutiny. A number of warning letters have been sent to such organizations as CDJ [...]
Posted on 03. Jun, 2014 by Ellen Leinfuss.
I recently attended the Global MedTech Compliance Conference in Barcelona. This year’s joint AdvaMed/Eucomed event, which drew the largest attendance ever, was riveted by the words of DOJ’s Jeff Knox. Knox leads the agency’s fraud section, overseeing more than 100 lawyers. As we know, much of the group’s focus is on rooting out fraud across [...]
Posted on 20. May, 2014 by Diane Ramey.
CMS will continue to monitor Part C and Part D Plan Sponsor call centers in 2014. CMS has contracted with IMPAQ International, LLC to monitor call centers and ensure compliance with CMS standards. CMS will be conducting two call center studies in 2014. The first call center study will look at timeliness; it will look at current enrollee beneficiary call [...]
Posted on 14. May, 2014 by Ellen Leinfuss.
I take six each morning, but my husband takes >10 and my kids take a bunch. How many dietary supplements (ok, call them vitamins or nutritionals) do you take each day? Sixty-eight percent of Americans take them, driving a market of almost $40 B. But what do we really know about these products? Where were [...]
Countries from India to Canada, and from Russia to Japan, are intensifying their scrutiny of medical device development, manufacturing, importation and distribution. Until recently, medical devices have not been as tightly regulated as pharmaceuticals. That is changing, however, as the market for medical devices escalates and the production of those devices becomes ever more global. [...]