White Papers

Best Practices: Medicare Advantage and Part D Plans	July 2008: Learn how Medicare health plans are meeting the latest CMS training requirements for sales agents,leveraging innovative Web-based learning technology and authoritative content.
Proficiency, Testing and Best Practices	A knowledgeable workforce is the cornerstone of an organization’s compliance, health and safety effort. It is also a defining factor in its ability to meet performance, efficiency and risk management goals. Many organizations use testing to determine how knowledgeable their workforce is, and tests can also measure the proficiency of their workforces. This paper reviews the latest thinking and best practices for building tests that ensure a knowledgeable, productive workforce.
Safety Pays	November 2007 -- Maintaining a culture of safety translates into improved productivity,profitability and risk management for companies in high-risk sectors, such as engineering and construction. Achieving and maintaining that culture requires the proper blend of learning resources, approaches and technologies. Kaplan EduNeering has partnered with organizations recognized as safety leaders to communicate, train and reinforce the culture of safety for employees, subcontractors and vendors. These experiences form the basis of this paper, which offer practical insight and resources for building a true safety culture.
How Industry Benefits from FDA's Online Training Program	September 2007 -- Life science companies have a strong incentive to re-examine the training initiatives that support their regulatory compliance and financial security. Kaplan EduNeering is FDA’s longtime partner in creating, administering and continually expanding ORA U Online, which ensures the competency of more than 30,000 federal, state, and local investigators.The same technology and knowledge resources used by FDA are available to the regulated community through a unique agreement with Kaplan EduNeering. This paper examines the technology and curricula chosen by FDA – and the competitive advantage for businesses that adopt the same program to ensure the compliance and performance of their workforce.
Improving Competitiveness through Broker/Agent Training	Inadequately trained brokers and agents of MA and Part D plans pose an unacceptable risk to Medicare beneficiaries. Based on the experiences of scores of healthcare clients, the article discusses best training practices for a dispersed workforce that includes both employees and subcontracted personnel.
Employing Secure Online Site Initiation Practices	August 2007 -- This article explains how a secure, online clinical knowledge solution can minimize delays in study initiation and patient enrollment by assuring that study team members have completed mandatory training before performing study procedures.
The Lessons of Texas City	August 2007 -- In June 2007, OSHA released instructions for implementing a National Emphasis Program (NEP), dedicated to reducing or eliminating workplace hazards associated with the catastrophic release of highly hazardous chemicals at petroleum refineries.OSHA will be inspecting approximately 81 petroleum refineries over a two-year period. Industry leaders can view this regulatory activity as an opportunity to deploy learning management programs that test comprehension and provide audit trails of employee and contractor participation, thus strengthening the safety culture throughout the organization.
Getting the Relationship Right Between Pharma and Physicians	The Department of Justice (DOJ), as well as many states, are stepping up investigations and enforcement of the federal Anti-Kickback Statute, the federal False Claims Act, and a growing number of state False Claims Acts. This article, published in Pharmaceutical Commerce, discusses best practices for properly managing these physician relationships.To view on the Pharmaceutical Commerce web site, copy and paste this Web address into your browser field: http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=540
Medicare Part D Compliance...Best Practices	The implementation of Medicare Part D poses unprecedented opportunities - as well as complex compliance challenges - for prescription drug plans (PDPs). This paper examines the best practices for key compliance issues identified by CMS and employed by Kaplan EduNeering’s 40 health plan clients: training, monitoring and auditing, and critical information management.
Quality and Compliance...Best Practices and Benchmark Study	April 2007 -- As pharmaceutical and medical device companies continue to innovate, so too must the methods they use to measure the value of their compliance management programs. This paper summarizes compliance benchmarks that leading companies have applied to address FDA regulatory issues, highly publicized safety issues, product recalls, and other factors that affect overall business performance and growth.
Integrating ComplianceWire with a Document Management System to Improve Training	April 2007 -- This paper details an actual client project in which a widely-used documentmanagement system was integrated with Kaplan EduNeering’s ComplianceWire® knowledge and compliance management system. It is applicable to other DMS systems routinely linked by pharmaceutical and medical device companies. The paper is based on a report prepared by the client and provided to EduNeering to share as a “best practice.”
Ensuring the Knowledge Needed for Process Safety	February 2007 -- Safety issues uncovered at BP’s Texas City Refinery after the facility’s fatal 2005 accident are not reserved for BP or the chemical/refining industry. This white paper discusses some of the findings made by the BP US Refineries Independent Safety Review Panel, and then suggests how companies can apply sound knowledge management principles to assure safe operations in compliance with both regulatory and corporate standards.
Understanding the Risks of Regulatory Non-Conformance	February 2007 -- This white paper represents a transcript from a recent breakfast roundtable program featuring EduNeering’s President and CEO Donald A. Deieso as moderator, and three industry leaders who addressed the financial risks of regulatory non-compliance. In attendance were chief financial officers and chief compliance officers, who learned about the intersection of risk management, regulatory compliance, and financial performance.
The Impact of Regulatory Compliance on European Medical Device Manufacturers Selling into the US Market	January 2007 -- The European medical device trade organization estimates the global market for medical devices at E184 billion. The global market has two main players, with the US representing 43% and the European Union claiming 30%. This white paper makes specific recommendations for medical device companies seeking market growth in the US or in the European Union, and who need to stay abreast of specific compliance standards. Please note this white paper is in A4 format; for letter (U.S) format, please send an e-mail to rob.sims@kaplan.com
The Business Advantage of Compliance-Based Performance	December 2006 -- Written by Denise Queffelec, VP, Life Science Division, EduNeering, this technical article makes the case that compliance-based performance improves efficiency, communication and performance improvements at all levels of an organization. The article was published in the December 2006 issue of PT Sourcing and Management Monthly, a sister digital magazine to Pharmaceutical Technology.
Assuring the Effective Use of Standard Operating Procedures (SOPs) in Today’s Workforce	December 2006 -- According to the FDA, the leading causes of Warning Letters and GMP citations in 2005 were “Responsibilities of Quality Control Unit” (21 CFR 211.22) and “Testing and Release for Distribution” (21 CFR211.165), David Peterson, Director, GMP and Quality Systems at EduNeering, offers several practical ways to implement an effective SOP compliance program, so that it helps the quality control unit’s ability to fulfill its mandate. This technical paper was published in the September 2006 supplement of International BioPharm.