UL Press Releases

AdvaMed/MTLI and UL EduNeering Introduce Certificate Program for Medical Technology Professionals

October 1, 2012 – Princeton, New Jersey and Washington, DC – UL EduNeering, part of UL (Underwriters Laboratories), a global independent safety science company and AdvaMed, the world’s largest medical technology trade association, announced the launch of the AdvaMed Regulatory and Compliance Certificate (ARCC) Program. This online certificate program is designed to enhance professional development for medical technology professionals and allow them to keep abreast of a rapidly changing environment. The ARCC program provides the latest information on relevant medical device issues and FDA regulations as well as practical information and skills to apply on the job.

The ARCC program, an online certificate program jointly developed between AdvaMed and UL EduNeering, offers three separate program options (tracks) and leverages UL EduNeering’s extensive online libraries, including both FDA and AdvaMed-approved content.  Each track includes 3-4 required courses and 6-7 electives, which have been specifically tailored to roles within the medical technology industry.  Each course is mastery-based, self-paced, interactive, and takes 30-45 minutes to complete.  An AdvaMed certificate is awarded at the completion of the track.

The three tracks are:

  • Corporate Compliance – for compliance, legal and sales/marketing professionals. Example topics include: Basics of AdvaMed Code, Introduction to Medical Device Compliance, FCPA/Global Anti-bribery, and HIPAA/Privacy Guidelines;
  • RA/QA – for Medical Device regulatory and quality professionals. Example topics include: Regulatory Filings: 510(k), PMA, and IDE, Introduction to Quality System Regulation (QSR), Handling a Product Recall, ISO 14155: Obligations of Sponsors & Monitors for Medical Device Trials;
  • Medical Technology Overview – for Medical Device Industry Generalist. Example topics include: Global Regulatory Strategy and Planning for Medical Devices, FDA Inspections, and Complaint Management.


“The launch of the ARCC program is a relevant and timely collaboration of our long-standing partnership with AdvaMed. We have worked side by side with AdvaMed over the years to support the medical technology community through thought leadership and relevant educational outreach and compliance programs,” noted Lisa Clune, UL EduNeering’s President. “Today’s medical technology organizations demand mastery of specific regulatory compliance and quality issues to remain competitive. Participation in the certificate program sends a clear signal to employers, clients and constituents that professionals are committed to the industry.”

Added Stephen J. Ubl, president and CEO of AdvaMed, “Supporting professional education in the rapidly-changing medical technology industry is a core part of AdvaMed’s mission. We are pleased to partner with UL EduNeering to offer this very timely and important program.”

As the exclusive online training partner for compliance solutions to AdvaMed, UL EduNeering brings its years of proven enterprise-wide compliance management experience to the medical technology industry.

 
About UL EduNeering
UL  EduNeering (www.uleduneering.com) is part of UL (Underwriters Laboratories), a global independent safety science company offering expertise across five key strategic businesses: Product Safety, Environment, Life and Health, Knowledge Services and Verification Services.

UL EduNeering develops technology-enabled solutions for improving business performance and assuring regulatory compliance. For more than 30 years, the company has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors using proprietary learning management platforms that integrate business, learning and technology.

About UL
UL is a premier global safety science company with more than 100 years of proven history. Employing nearly 9,000 professionals in 46 countries, UL is evolving the future of safety with five distinct business units – Product Safety, Environment, Life & Health, Verification and Knowledge Services – to meet the expanding needs of customers and the global public. For more information on UL’s family of companies and network of 95 laboratories, testing and certification facilities, go to UL.com.

About AdvaMed
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org

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UL Broadens Regulatory and Compliance Solution for Life and Health Sciences Sector with Acquisition of EduNeering

NORTHBROOK, Ill. / PRINCETON, NJ. – April 9, 2012 – UL, a world leader in advancing safety, has acquired EduNeering, the leading provider of compliance and training solutions for the life and health sciences sector, from Kaplan Inc., a leading international provider of educational and career services. The addition of EduNeering significantly enhances the online training and software offerings of UL’s Knowledge Services business unit with a solution focused on pharmaceuticals, medical devices, clinical research education and U.S. Food and Drug Administration (FDA) inspection and enforcement.

EduNeering features governance, risk management and compliance (GRC) operational software and online training that are relied upon by more than 400 companies across 50 countries. It serves as the online compliance learning partner for the FDA, the Advanced Medical Technology Association (AdvaMed), Duke Clinical Research Institute and the Drug Information Association, among others. In addition to life and health sciences solutions, EduNeering’s courseware addresses compliance and regulatory issues in the energy, manufacturing, construction, engineering, health plan and food processing sectors.  

Since 1999, EduNeering has maintained a unique partnership with the FDA, under which it develops and maintains the agency’s online training, documentation and validation technology system for ORA-U, the agency’s virtual university. ComplianceWire®, EduNeering’s learning management technology, has been used by the FDA to train and certify more than 35,000 federal, state, local and global investigators. More than 150 pharmaceutical, medical device and biologic companies also depend on ComplianceWire® to organize, distribute and monitor all training and qualification activities.

“Adding EduNeering extends our commitment to product safety and helps people and the companies they work for to be smarter, safer, healthier, more efficient and more effective,” said Patrick Boyle, president of UL Knowledge Services. “We are adding a high-caliber staff, a highly scalable learning management platform and an extraordinary course library that extends our world-class training software and solutions to the health sciences community.”

Knowledge Services, UL’s fast-growing training, advisory and software solutions business unit, will integrate EduNeering’s team of 85 employees, its technology platform and the course library of 700 online training modules, which also cover energy operations, manufacturing, ethics, environmental health and safety, engineering and construction, and food safety. EduNeering is the second acquisition to join Knowledge Services in six months, following the December purchase of Occupational Health and Safety software solutions leader PureSafety.

“We’re thrilled to be joining the world’s most recognized safety organization, and dedicating our people, technology and services to the advancement of UL’s global mission,” said Lisa Clune, president of EduNeering. “UL affords us an extraordinary growth platform of global resources, reputation and social mission that will bear fruit for our team and customers alike.”  

Ms. Clune will continue to manage EduNeering, which will remain headquartered in Princeton, NJ, and will continue to help guide the business, which will be branded under UL. She will report to William Grana, vice president of Knowledge Services and head of its software capabilities.

About EduNeering
EduNeering (www.kaplaneduneering.com) develops technology-enabled knowledge solutions for assuring regulatory compliance and improving business performance. EduNeering is headquartered in Princeton, NJ, and has offices in Houston, TX, Bloomsburg, PA, and London, UK. EduNeering was acquired by Kaplan, Inc. in early 2007.

About UL
UL is a premier global safety science company with more than 100 years of proven history. Employing nearly 9,000 professionals in 46 countries, UL is evolving the future of safety with five distinct business units – Product Safety, Environment, Life & Health, Verification and Knowledge Services – to meet the expanding needs of customers and the global public. For more information on UL’s family of companies and network of 95 laboratory, testing and certification facilities, go to UL.com.

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Kaplan EduNeering and Asia Pacific Bio Intelligence (APBI) Form Alliance to Help Life Science Clients Meet China’s Regulatory Requirements

February 29, 2012 - Princeton, NJ (USA) and Shanghai (China) — Kaplan EduNeering and Asia Pacific Bio Intelligence, LLC (APBI) today announced a strategic alliance that will result in additional services to both EduNeering and APBI clients, as they work to meet increasing international regulatory requirements throughout the healthcare supply chain.  

“We are excited to work with Kaplan EduNeering, a leader in providing online regulatory compliance training, to share their services in China,” said APBI President Seth J. Goldenberg, Ph.D. “As many companies are looking to enter the China market for distribution, manufacturing, or R&D it is crucial that their staff understand global international regulatory requirements.  In addition, domestic Chinese firms looking to export must be prepared to meet the demands of the FDA and EMA.  Many firms we work with in China need a cost-effective regulatory compliance training system that Kaplan can deliver.”

APBI helps bridge U.S. and Chinese Healthcare, Pharmaceutical and Medical Device organizations.  APBI’s founders and staff are made up of former U.S. FDA and Chinese SFDA members.  With offices in the U.S. and China APBI supports clients through on-site GMP Audits, regulatory strategy and approval, and many other services to help grow businesses in China. APBI is committed to helping companies overcome the bureaucratic, linguistic, and cultural differences that typically impede entering a foreign market in a timely and cost effective manner.

“This collaboration with APBI will give EduNeering’s clients access to a proven team of regulatory experts to support their growth,” said Lisa Clune, Kaplan EduNeering’s President. “Through custom course creation, on-site audits to determine specific training needs, and regulatory strategy APBI can enhance the existing regulatory compliance material we provide. Together, EduNeering and APBI can support initial product entry and compliance throughout the product lifecycle, from R&D through production and export/import.”



About Kaplan EduNeering:
Kaplan EduNeering (www.kaplaneduneering.com) develops technology-enabled knowledge solutions for assuring regulatory compliance and improving business performance. Kaplan EduNeering is headquartered in Princeton, NJ, and has offices in Houston, TX, Bloomsburg, PA, London, UK, Hong Kong, and Beijing China. Kaplan EduNeering is part of Kaplan Inc., a leading global provider of educational services to individuals, schools, and businesses and a subsidiary of The Washington Post Company (NYSE: WPO). 



About Asia Pacific Bio Intelligence, LLC:
Asia Pacific Bio Intelligence LLC (www.ap-bi.com), a privately held consulting and project management company, provides services for: market analysis, distributor identification, partner identification, regulatory strategy and approval, healthcare provider training, hiring of key staff, office setup, and many other services to help you grow your business in China or the U.S. APBI is committed to helping companies overcome the bureaucratic, linguistic, and cultural differences that typically impede entering a foreign market in a timely and cost effective manner.  APBI is headquartered in Philadelphia, PA and has an office in Shanghai, China.

FOR INFORMATION:
Kaplan EduNeering:
USA: Ellen Leinfuss,
1 609 627 5390 (USA) 
ellen.leinfuss@kaplan.com

China: Ryan Carpentier,
+852 2116 3308 (Hong Kong)
ryan.carpentier@kaplan.com

Asia Pacific Bio Intelligence, LLC (APBI):
Seth J. Goldenberg, Ph.D.
USA: (215) 854-4087
China: +86 (021) 62259600
seth.goldenberg@ap-bi.com

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Kaplan EduNeering and CrossKnowledge Join Forces to Offer Leadership and Management Training Content on Award-Winning Learning Platform

October 19, 2011 PRINCETON, N.J. (USA) and LONDON (UK) — Kaplan EduNeering and CrossKnowledge today announced a new collaboration that will offer EduNeering clients a new array of business and leadership curricula and CrossKnowledge clients use of EduNeering’s award-winning Learning Management System. Part of global education company Kaplan, Inc., EduNeering is a leading provider of compliance and knowledge management solutions. CrossKnowledge is the premier choice of distance learning solutions for leadership and business skills development in Europe.

“We are fortunate to collaborate with a company like Kaplan EduNeering, which is a leader in providing online regulatory compliance training to many global and multi-national organizations,” said CrossKnowledge CEO Mickaël Ohana.  “As the regulatory landscape continues to change across industries, we feel that the depth of our leadership and management training material will prove to be a critical component to Kaplan EduNeering’s compliance training solutions.”

CrossKnowledge provides 15,000 plus learning contents (i.e. online sessions, self assessments, action tips, videocasts, business reviews, etc.) that cover more than 100 business management and leadership topics. Developed by management and leadership experts from such renowned graduate business schools as Cambridge, Harvard, HEC Paris, and IMD, among others, these curricula provide a wide breadth of employee training products. Among the areas covered are leadership, diversity, value creation, client orientation, change management, and strategy. All focus on professional skills development.

“This collaboration with CrossKnowledge will give Kaplan EduNeering’s clients access to an even larger diversity of management training options, enhancing their corporate e-Learning and professional development programs,” said Lisa Clune, Kaplan EduNeering’s President. “Even better, EduNeering clients can access this broad array of management and leadership learning objects through the same award-winning LMS on which they depend to manage and deploy their regulatory compliance training needs. With offerings in over 16 languages, these products will serve the needs of our ever-growing multi-national clientele.”

About Kaplan EduNeering
Kaplan EduNeering (www.kaplaneduneering.com) develops technology-enabled knowledge solutions for assuring regulatory compliance and improving business performance. Kaplan EduNeering is headquartered in Princeton, NJ, and has offices in Houston, TX, Bloomsburg, PA, London, UK, Hong Kong, and Beijing China. Kaplan EduNeering is part of Kaplan Inc., a leading global provider of educational services to individuals, schools, and businesses and a subsidiary of The Washington Post Company (NYSE: WPO).

About the CrossKnowledge Group
Founded in 2000, CrossKnowledge (www.crossknowledge.com) is the European leader in remote development of leadership and managerial skills, using new technologies. CrossKnowledge designs, develops and markets the fullest catalogue on the market, with more than 15,000 multilingual learning objects, tackling all management and leadership topics. Its “Faculty” comprises the best authors, professors and Management professionals from the most renowned Business Schools in the world, such as Harvard, Stanford, IMD and HEC. CrossKnowledge has offices in the United Kingdom, France, Belgium, Italy, the Netherlands, Spain and Switzerland, and thanks to strategic partnerships, in Morocco, India, China, Japan and Canada, CrossKnowledge already has 2.5 million users.

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Kaplan EduNeering Announces Winners of 2011 Knowledge Summit Achievement Awards

May 12, 2011 – Princeton, New Jersey – Kaplan EduNeering, the leader in Cloud-based compliance learning solutions, announced today that it will award six clients with an achievement award at its annual Knowledge Summit, being held in Alexandria, VA, May 11-13. The Knowledge Summit Achievement Awards recognize notable accomplishments by Kaplan EduNeering clients in 2010.

The winning companies were chosen from an open call to Kaplan EduNeering clients for case studies submissions. The awards are given to clients that have exemplified aptitude and excellence in specific compliance learning technology categories. In recognition of their achievements, the award winners will receive a crystal award and a donation to the charity of their choice in the name of their organization.

This year’s Knowledge Summit Achievement Awards winners are:

  • Bausch + Lomb - Operational Excellence
  • CoreLab Partners, Inc. - Technology
  • Medical Devices & Diagnostics Companies of Johnson & Johnson - Training
  • Kimberly-Clark Corporation - Custom Courses
  • Teradata Corporation - Compliance
  • Teva Pharmaceuticals USA, Inc. - Innovation

“These award winning case studies are only made possible by the untold efforts of project owners and administrators within the client organizations, as well as the project and business team members within Kaplan EduNeering,” said Ellen Leinfuss, SVP of Sales and Marketing for Kaplan EduNeering. “We see these awards as a reflection of our ongoing drive and commitment to partner with clients to address their unique compliance and business performance goals,” she added. “Our success is the success of our clients in deploying effective compliance and regulatory solutions.”

The Knowledge Summit is an annual event that allows Kaplan EduNeering’s clients and partners to network and learn compliance and training best practices from their peers and leading experts. “The Knowledge Summit provides the opportunity for our clients to garner best practices around their regulatory and compliance solutions,” said Lisa Clune, President of Kaplan EduNeering. “We have over 150 clients participating this year representing 70 different organizations from various industries including life science, energy, health plan, retail, government and industrial. This level of participation is a validation of the business value that Kaplan EduNeering delivers to our clients.”

About Kaplan EduNeering
Kaplan EduNeering (www.kaplaneduneering.com) develops technology-enabled knowledge solutions for assuring regulatory compliance and improving business performance. Kaplan EduNeering is headquartered in Princeton, NJ, and has offices in Houston, TX, Bloomsburg, PA, London, UK, Hong Kong, and Beijing China. Kaplan EduNeering is a subsidiary of Kaplan Inc., a leading global provider of educational services to individuals, schools and businesses. Kaplan Inc. is a subsidiary of The Washington Post Company (NYSE: WPO).

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