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 affair...

An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and also a form by which required information is recorded. The effectiveness of these items will...

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rathe...

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on speci...

An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information...

The CIO Government Technology will bring together leading CIOs, CISOs, and government IT executives from across the U.S. to confront and overcome current industry issues, cybersecurity, and cloud computing. This event will explore critical topics and challenges currently impacting government agencies, and emerging technologies that will resolve the issues. ​ The goal of the CIO Government Technology Conference is to create an environment...

The American Council for Technology and Industry Advisory Council (ACT-IAC) invites you to the Mobile Health Forum on Thursday, April 20th at the Renaissance Washington in Washington, D.C. Mobile Health Apps and Telehealth applications have the potential to transform the standard approach to treating, monitoring, and educating the patient populations. These bi-directional initiatives – via voice, text, data, camera images and or video f...

Over the next four to six years, healthcare organizations will find themselves in the midst of a shift in the way that healthcare is administered and monitored. According to research, patients will begin taking ownership of their healthcare which will create a deep ripple effect across IT networks that enable the day-to-day activities of the military. To address these seismic changes, the military is looking at how technology solutions will su...

Join us for the 2017 Healthcare Forum to hear from leaders in both the public and private sector on digital healthcare, interoperability and cybersecurity. The new era of medicine incorporates technology to empower, improve access and outcomes for a variety of patient populations. As healthcare is still largely a fee-for-service model, balancing the need to ensure data sharing is secure and patient privacy is adequately protected is foundation...

OMICS International Conferences invites all the participants from all over the world to attend ' 8th World Congress on Cell & Stem Cell Research’ during March 20-22, 2017 in Orlando, USA which includes prompt keynote presentations, Oral talks, Poster presentations and Exhibitions.   The success of the Cell Science conference series has given us the prospect to bring the gathering in Orlando, USA. Since its commencement in 2011 Cell S...