Clearly, cybersecurity is big problem for everyone. Financial service companies, in particular, face a tough task in adhering to compliance frameworks and managing Cybersecurity risks, while at the same time providing services at competitive prices. They need to focus on regulatory frameworks, compliance measures, and technology solutions in response to emergent regulatory and compliance requirements. Recent events have created a movement towa...

Decision makers from business, industry and government must now seek integrated energy solutions — solutions which assure both a secure and affordable power supply, and effective management of both energy and overall operational costs. Globalcon, presented by the Association of Energy Engineers, is designed specifically to facilitate those who need to get up to speed on the latest developments in the energy field, explore promising new t...

Course "A Risk Based Approach To IT Infrastructure Qualification & Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview:GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to pro...

Moving from DIACAP to Risk Management Framework (RMF)? The Struggle is Real – Ease the Way with Splunk! The struggle is real as the DoD moves from DIACAP to RMF. System owners are challenged to adopt technology that can address the more dynamic controls required by the Risk Management Framework, particularly in the audit control family where the ongoing collection and analysis of log data is critical. Enter Splunk, a next-generation moni...

Overview:This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The sec...

REI Systems and the George Washington University’s Trachtenberg School of Public Policy & Public Administration will host a Grants Management Breakfast (GMB) Forum. Our bimonthly GMB Forums bring together professionals from government, academia, and industry to share first-hand experiences in managing the full grants life cycle, resulting in real-world opportunities for process and performance improvement. Our guest speaker for this...

Does your agency have the processes in place to remain efficient while complying with rapidly changing policy and regulation? Join Bizagi for our first Public Sector Forum to find out. The all-day event will be held at the beautiful Mandarin Oriental. Network with leaders in government, attend meetings to discuss hot-button topics, and enjoy delicious meals and refreshments. At the end of the day you'll enjoy our closing networking session wit...

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...

An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and also a form by which required information is recorded. The effectiveness of these items will...

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...