Course "HIPAA - Putting an Organizational Compliance Program in Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place...

This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered: History and background of U.S FDA Laws and Regulations Classify Your Device Choose the Correct Premarket Submission for your device Compile the Appropriat...

Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration prevention, pers...

This workshop will provide a comprehensive overview of all the key aspects of Human Resources. It will cover areas of compliance as well as best practices. You will receive a comprehensive workbook for the workshop and you will come away with Human Resource tools that you can start to use immediately upon your return to work that will add value to your organization. You will also come away with "best practices" in key areas such as Hiring, Ter...

Course "FDA Device Software Regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with soft...

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...

Technology, Talent, and Trends You Need to Know How can you set yourself apart from the competition? How can technology and industry trends give you a distinct advantage in the marketplace? How can Deltek help you position your firm for growth this year? Deltek is coming to a city near you with a complimentary half-day event designed to give you the tools and resources you need to help you succeed this year. Grab your co-workers, share the upc...

Join F5 Networks and Carahsoft to earn two (ISC)2 CPE credits and discuss how to protect internet users with SSL Intercept technology. Learn how adversaries increasingly evade cybersecurity tools by using SSL/TLS as a cover of darkness for malicious activity and how AirGap Inspection with SSL Intercept technology peels back this cover and revitalizes network perimeter defenses. During this Security TechTalk, you will: Learn about the new Appl...

Overview: QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures a...

Course "Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on ho...