The Government Contractors Association is a professional, public organization designed to facilitate business owners and non-profits in winning federal contracts through education, resources, and relationships. When you join GCA, you get a FREE Quickstart 3 hour bootcamp that explains what government contracting is and how to get your piece of the American pie. In addition, we educate our members on how to utilitze the tools & resources of...

This workshop will focus on the progress to date in implementing the President’s EO on Cybersecurity with emphasis on key requirement: identification of High Value Assets, implementation of NIST’s Risk Management Framework (RMF) and Cybersecurity Framework (CSF). The CSF and RMF are critical for the federal government in its efforts to mitigate risk within enterprise information systems. The workshop will also discuss the relations...

The President issued an Executive Order (EO) on March 17, 2017 which emphasizes the need to maximize employee performance by better managing poor performance and conduct and ensuring transparency in the Performance Improvement Process (PIP). This Potomac Forum Training Workshop for Government will provide information for Agency Executives, Managers and Staff to meet the long term requirements for workforce accountability and performance manag...

Citizens today are more connected that ever before; increasingly expecting anytime, anywhere access to government services and information – via online, mobile and/or social. To continue to best serve and engage ever-connected citizens, government organizations and their industry partners must deliver innovative apps and mobile services that are highly secure and provide a user-friendly experience. With these opportunities in mind, be su...

EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission,...

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...

During the last two years, federal agencies have made tremendous strides toward improving the security of their networks, systems, and data. But it hasn’t been enough, and never could have been. Even as the federal government has put in place new, more sophisticated programs for defending against cyber threats, those threats have continued to evolve. Register today for the Cybersecurity Summit and hear Federal IT leaders from across gov...

This lesson will be addressing how practice/business managers (or compliance offers) 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. I will speak on speci...

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar products Why you should attend: The regulation of Biosimilars is very complex and the approach used by various regions differs. Professi...