HIPAA Becoming the Critical Compliance Training Topic for 2014

Posted on 16. Jul, 2014 by .

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. [...]

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SaaS Validation: Three Things You Should Know

Posted on 09. Jul, 2014 by .

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 [...]

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Managing Third Party Compliance Risk

Posted on 02. Jul, 2014 by .

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 [...]

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Dietary Supplements, the FDA and Your Organization

Posted on 19. Jun, 2014 by .

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 [...]

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DOJ’s Knox: Credit Will be Given for a Strong Compliance Program

Posted on 03. Jun, 2014 by .

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 [...]

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2014 Part C and D Call Center Monitoring Protocols

Posted on 20. May, 2014 by .

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 [...]

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Dietary-Supplement

Top 5 Reasons Dietary Supplement Manufacturers are Embracing cGMP Training

Posted on 14. May, 2014 by .

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 [...]

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Global Regulatory Trends for Medical Devices

Posted on 08. May, 2014 by .

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. [...]

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