Join us for our upcoming ISC2 NOVA Chapter meeting! Network with fellow professionals, earn CPE credits, and enjoy complimentary food and drinks.We are excited to have Valinder Mangat, Chief Innovation Officer @DRTConfidence share his insights. Valinder will provide a talk on Reduce Risk by Automating Compliance with OSCAL. Not a member? No problem! Come see what we're about and consider joining after. Don't miss out on this valuable opportuni...

Join the Identity Revolution Tour meetup in Washington, DC to learn how your peers are starting a cybersecurity movement at their organization with converged solutions and Zero Trust frameworks. Come network with our community over delicious food and drinks — all while earning CPE credit. The game has changed. And we can no longer play by the rules that defined the last generation of Identity. The move to the cloud, Zero Trust mandates,...

Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not recur. One of the most widely-used tools is the 8 Disciplines (8D) methodology. 8D requires you to identify and fix the problem immediately (put a ban...

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...

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 version to...

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...

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...