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...

The need to evolve is today's only certainty. With reimbursement down, accountability up, and patient expectations on the rise, what changes do you need to make to position your organization for success? The Revenue Cycle Solutions Summit brings together thought leaders, experts and financial decision makers from all across the United States to answer that question and more. Join us in Boston for an intense day of problem solving, innovation a...

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...

Governing looks forward to returning to Boston in November for the 2016 Massachusetts Leadership Forum. The Commonwealth has achieved important progress in the recent years, investing in local ecosystems to attract economic development and help propel future innovation and job growth as well as making great strides towards becoming a national leader in energy efficiency. Still, significant challenges remain yielding opportunities to partner wi...

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...

Go Ahead. Gain Insight, Ideas and an Action Plan VMware vForum is a free one-day event that offers a unique setting for IT professionals to engage with experts and learn about the latest technologies, tips, and trends in the field. It doesn't matter whether you are at the start of your journey or already have an advanced deployment plan—join us as we help you navigate your IT journey across cloud, virtualization and mobility and ultimate...

Government Technology’s passion is helping spread best practices and spurring innovation in the public sector. The Massachusetts Digital Government Summit is designed to do just that. The summit has an advisory board that gathers public sector and private sector leaders to create an agenda designed to make that passion relevant and actionable to the state and local government organizations attending the summit. Participants tell us they...

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...