APMP Bid & Proposal Con 2016 Wednesday, May 25 -- Saturday, May 28, 2016 Sheraton Boston Hotel 39 Dalton St. Boston, MA 02199 Conference Schedule Hear from thought leaders and visionaries, ready to share best industry practices that improve business processes and increase win rates. See how your organization's practices measure up. Check out the conference schedule here. Why Attend? APMP Bid & Proposal Con is the world’s largest...

At the Pop Health Forum 2016, we’ll dig deeper than ever into data and analytics, care coordination, and patient engagement – the cornerstones of a successful population health strategy. Come hear case studies, thought leadership and best practices from leading healthcare institutions who have worked through some of pop health’s toughest challenges. Learn actionable strategies you can implement at your own organization. Join...

Course "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: 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...

Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process v...

Overview: 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 preven...

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...