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...

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...

Our 146th Congress of Correction is an engaging, thought-provoking, six-day event offering multiple ways to network with industry professionals, find a mentor, get a sneak peek at emerging technology, and hone your leadership skills.

Two concentrated days on how to understand and use the Federal Acquisition Regulation in your daily contracting activities including in-depth analysis of the FAR system, the key contract clauses and contract forms. Provides comprehensive coverage of the FAR for new users and an advanced treatment of specific issues for experienced contract professionals. Course includes an explanation and demonstration of how to use the FAR online for research...

Information security training in Boston from SANS Institute, the global leader in information security training. At SANS Boston 2016, SANS offers hands-on, immersion-style security training courses taught by real-world practitioners. The site of our live training event on August 1-6, 2016, is the Omni Parker House, located along the Freedom Trail and at the foot of Beacon Hill, Boston Common, Quincy Market, and Faneuil Hall marketplace. SANS w...

The data stolen during a breach is used for many purposes, but especially for fraud. Security and fraud teams are working ever more closely together, both pre- and post-breach, to ensure that they are in the best possible position to defend, detect and respond. In this dual-track event intended for senior InfoSec and fraud professionals, we’ll focus on the latest fraud techniques and technologies, as well as a holistic, strategic approac...