The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways Thorough Understanding of HIPAA Rules What they are How they work together Why and How they were m...

Course "New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the...

Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal r...

When it comes to protecting your organization’s data, no one has all the answers, and going it alone can be a recipe for disaster. Whether it is the threat of cyberattacks from the technologically sophisticated, the misuse of protected health information by a well-intentioned employee or complying with HIPAA, the challenges are persistent and growing. The Boston Privacy & Security Forum brings you together with senior healthcare IT p...

Healthcare is undergoing a massive transformation. That’s no secret. Reimbursement is shrinking, providers are being asked to shoulder more risk, and patients are more involved in their care than ever. The ability to use analytics to transform data into actionable information – smarter business and clinical decisions – will play a big role in who survives this transformation. That’s not hype – it’s reality....

Overview: The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003...

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are known to be...

Course "Fundamental Laboratory Record Keeping and Compliance Issue" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Most of the focus on a laboratorys compliance to Good Laboratory Practice (GLP) or to the analogous ISO 17025 is on items such as the Standard Operating Procedures, training, quality assurance testing, and the statistical assessment of perf...

Course "HIPAA Privacy Security - Time to Get Serious" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I have conducted over 400 risk assessments for business associates and covered entities alike as well as worked directly with the Federal government in terms of auditing. This seminar will go into great detail about what is going on in the HIPAA Security...

At the Pop Health Forum 2016, we’ll dig deeper than ever into data and analytics, care coordination, and patient engagement – the cornerstones of a successful population health strategy. Come hear case studies, thought leadership and best practices from leading healthcare institutions who have worked through some of pop health’s toughest challenges. Learn actionable strategies you can implement at your own organization. Join...