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...

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of do...

OVERVIEW You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient. The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV). This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System...

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...

We would like to welcome you to the 3rd Annual Pre-Filled Syringes Summit on September 28th – 29th, 2017 in Barcelona, Spain. This event provides the appropriate platform for industry leaders to discuss best practices as well as new developments in Pre-Filled Syringes (PFS). The Summit will provide a broad overview of market trends and device needs; technologies and innovations; delivery aspects of parenteral drugs; as well as regulatory...

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...

Securing Federal Identity 2017, a highly focused and high-energy event, will feature the significant policy issues and technology developments for today’s federal identity and security industry. The select group of speakers on the agenda and security companies in our exhibit area will highlight the present and future direction of the government’s efforts to manage identities and control access across all federal agencies. Don...