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...

Unprecedented Counterintelligence Threats: Protecting People, Information and Assets in the 21st Century INSA Counterintelligence Symposium At this unique event, “Unprecedented Counterintelligence Threats: Protecting People, Information, and Assets in the 21st Century,” senior officials from the public and private sectors will provide insights into these threats and identify effective ways of addressing them. Among the conference...

HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess th...

Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audi...

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself,...

This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIP...

This course provides an in-depth look at testing the controls using NIST SP 800-53A Rev. 4 and ensuring the use of the Risk Management Framework (RMF) for Federal Security Systems. The focus of the course is an in-depth explanation of each NIST SP 800-53 Revision 4 controls to include what method should be used to test and validate each security control in accordance with NIST SP 800-53A, Rev. 4 and NIST SP 800-115, what evidence should be gat...

This course equips the student with an overview of the system Authorization and Assessment process (also known as A&A) and the Risk Management Framework (RMF) for DoD IT and National Security Systems (NSS). This course reviews, at an in-depth level, NIST SP 800-37, NIST SP 800-53, Rev 4, DoDI 8510.01, DODI 8500.1, CNSS 1253, and other crucial directives that govern this process. In addition to the classroom instruction, the student will al...

An educational symposium for military personnel, this learning event will examine The Risk Management Framework (RMF) for DoD Information, as outlined in DoD Instruction 8510.01. The Federal Executive Briefing will be highlighted by a Keynote Briefing by a senior level DoD official, who will give an overview of RMF, discuss the transition from the DoD Information Assurance Certification and Accreditation Process (DIACAP) to RMF and provide a...

There’s a dynamic, growing community of Feds who are passionate about data – and now you can meet them face-to-face. Have conversations with experts and peers. Learn best practices and get insider tips.Qlik’s Federal Summit will be filled with agency stories, demonstrations, tips, discussions, and insights about innovations in data discovery from Qlik plus mission-focused and operational analytics applications, and more. Join us!