We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization. Why should you Attend: Because as much as we try, most regulated industries don't have a set approach for developing a compliance program that is integrated into the fabric of their organization, that serves real valuable functions to improve operations, improve and maintain human competenc...

Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program. Areas Covered In the Session: Discuss what FDA is...

We live in a 24-hour news cycle world, where reporters are harried and working on multiple stories every day. Time is of the essence, and if your story idea is sitting in an inbox with hundreds of others, how will it get noticed? Government communicators have to stay ahead of the game to reach busy journalists who thrive on urgency. Make your pitches irresistible to journalists by becoming an information architect. Through research and shaping...

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...

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...

The goal for this course is to provide an understanding of cybersecurity leadership focused on people and not just technology and policy. It will give you an overview of frameworks to support your risk management activities. It is highly useful to any organizational executive, or leader seeking an understanding of building cybersecurity cultures and governance. Purpose: The word cybersecurity is thrown around, used and abused to scare people i...

Federal Mobile Strategic Sourcing Day, hosted by the Mobile Services Category Team and the Advanced Technology Academic Research Center, will be held on Tuesday, August 1 from 8:30 a.m. to 3:30 p.m. in the Auditorium at GSA Headquarters, 1800 F St., NW, Washington, D.C. Note: Registration opens at 8:30 a.m., please arrive at least 15 minutes early to clear security. This educational event for the Federal contracting community is open to govern...

Office Hours is a designated time for GCA members to receive consultation time to review government contract concerns. For example: proposal considerations team agreements assessment analysis strategy planning and more What: Office Hours for GCA Members When: Tuesdays at 6:00 pm (except 2nd Tuesdays) Where: 3300 Buckeye Road; Suite 500; Atlanta, GA 30341 Register: http://govassociation.org/event-2588634 Who Should Attend: GCA members What Will...

Information security training in Washington, DC from SANS Institute, the global leader in information security training. At SANSFIRE 2017, SANS offers more than 45 hands-on, immersion-style security training courses taught by real-world practitioners. The site of SANSFIRE 2017 (July 22-29) is Washington Marriott Wardman Park. Event Schedule: One-Day Course: Begins on Sunday, July 23 Two-Day Courses: Begin on Saturday, July 22 Four-, Five-, and...