Overview: Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or faci...

This lesson will be addressing how law firms who work with protected health information 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 as it relates to pa...

Training Options Duration: 60 Minutes Tuesday, November 28, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important...

Training Options Duration: 90 Minutes Wednesday, November 22, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have...

Training Options Duration: 60 Minutes Friday, November 17, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an i...

Overview: We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager. Why should you Attend: On average it takes ten successful projects to make up for one really bad project. If your projects are finishing late, if your teams turn over faster than a freshman class in college, if your projects are losing money, then you need to take this course. Areas Cover...

Training Options Duration: 90 Minutes Wednesday, November 15, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: Whenever workers enter an area where there is a possibility of exposure to hazardous or toxic substances, or where there is a possibility of injury or harm due to entering a space with only one way in and out, and where only a single employee may work, OSHA has provided written regulations requiring that the space be designated as a hazar...

Overview:Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators. Why should you Attend: Perhaps you're a development manager, hoping to improve both productivity and quality. Or you are a quality assurance manager, facing a demand from management and development to permit a move to Agile. Areas Covered in the Session:TIR 45 comes at a much ne...

Overview:The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Why should you Attend:How to Build a Compliance StrategyMinimizing Cost while Maximizing ComplianceKnowing the policies and procedures that must be developed and maintained to support the clinical trial system in operation Areas Covered in the Session:FDA T...

Overview: One of the major requirements of the health care organization to be HIPAA compliant is to develop and implement a set of HIPAA privacy and security policies and procedures. This can be a daunting task for those not knowing where to start and what a set of HIPAA privacy and security policies and procedures should look like. For the cost conscious health care organization, the HIPAA policies and procedures can have multiple uses: first...