Solutions Overview:Online ComplianceTraining
Agenda  •   About Us  •   Our Partnerships  •   Our Focus on Learning and Compliance  •   Our Focus on Employee Performanc...
About Kaplan EduNeering    • 31 years in business    • A Leader Among      Software-as-a-Service      (SaaS) Learning     ...
Three-Time Winner for Best Compliance LMS                          • Brandon Hall Group is one of the                     ...
Breadth of Clients, Deep Life-Science Expertise
Key Differentiators
Our Solutions At-a-Glance     Kaplan EduNeering Platform                       Professional Services •   Web-based Learnin...
Partnerships & Alliances
Unique Relationship with FDA •   Exclusive CRADA between FDA’s Office of Regulatory Affairs (ORA)     University and EduNe...
Exclusive Relationship with AdvaMed                        Exclusive Online Compliance                        Partner to A...
Strategic Alliance with DIA                              Providing Online Education for Drug and                          ...
Strategic Alliance with CrossKnowledge                           CrossKnowledge designs, develops and                     ...
Our Focus on Learning and Compliance                                      Sales:                             “We need to e...
SaaS Model Supports Multiple Communities
Built From the Ground Up SaaS Model                          • Kaplan EduNeering Owned and                            Mana...
Available & Reliable  • Data centers in both Houston, TX and    Princeton, NJ  • 99.99+% uptime since 2005  • Redundant po...
Our Proven Quality System• Fully Documented SDLC• Change Control• Document Management• Management Responsibility• Nonconfo...
Our Proven Deployment Process• Leveraging best practices in Knowledge  Management processes from industry experience• Part...
Continuous State of Training & Development
The ROLES Based Training Formula •   Review your training matrix •   Organize you training into Curricula •   Leverage Use...
ROLES : Review Your Training Matrix         Company      Corporate / Divisional Requirements           Level              ...
ROLES: Review Your Training Matrix OLES•   Review what you have now (be honest)•   Determine what is missing•   Perform a ...
ROLES: Organize training into Curricula       O
ROLES: Organize Training Into Curricula       O  •   Manageable Size  •   Curriculum Types  •   Due Dates / Retraining Per...
ROLES: Leverage User Groups   ES                              Each site receives its                                own se...
ROLES: Leverage User Groups   ES • User Groups     - “Containers” for users     - Labels / characterizes / groups common u...
ROLES Based Training Matrix    Role-Based User Groups             Role-Based Curricula                                    ...
ROLES : System Maintenance  • Monitor the system through standardized reporting  • Standardize nomenclature and other meta...
ROLES: Qualification ReportingROLES
ROLES: Qualification ReportingROLES
ROLES: Compliance DashboardROLES
Managing Organizational Behavior and                                                           PerformanceDocumented     ...
Let’s Take a Look!
The End of the “Project”… …but just the  beginning of the partnership!
Platform   Client ServicesConcierge Help DeskResponding quickly to customer inquiriesTechnical SupportThorough understandi...
Platform   Client ServicesKnowledgeable…All client service representatives are KaplanEduNeering staff, with extensive prod...
Our Global Response Process:    During Business Hours (EST)    During Non-Business Hours (EST)     Full-time staff handles...
Additional Benefits of our Partnership•    Quarterly Multi-Media Communications•    User forums and events      – Annual K...
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EduNeering Online Compliance Training Solutions Overview: Life Science

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EduNeering Online Compliance Training Solutions Overview: Life Science

  1. 1. Solutions Overview:Online ComplianceTraining
  2. 2. Agenda • About Us • Our Partnerships • Our Focus on Learning and Compliance • Our Focus on Employee Performance • Questions & Answer Period
  3. 3. About Kaplan EduNeering • 31 years in business • A Leader Among Software-as-a-Service (SaaS) Learning Management Systems • Focused on Regulatory and Compliance Learning • 400 Clients, spanning 67 countries, in 30 languages • Joined the Kaplan Family in 2007 Our Mission: Deliver Knowledge Solutions that Assure Compliance and Improve Business Performance
  4. 4. Three-Time Winner for Best Compliance LMS • Brandon Hall Group is one of the leading research firms in training and development • Learning Management Technology for Compliance Learning • The entries were evaluated by independent judges around the world
  5. 5. Breadth of Clients, Deep Life-Science Expertise
  6. 6. Key Differentiators
  7. 7. Our Solutions At-a-Glance Kaplan EduNeering Platform Professional Services • Web-based Learning Management • Integration with Mission-Critical System Applications (HRIS, DMS, MES, etc) • Designed to Meet 21 CFR Part 11 • Technical Consulting • Employee Transcripts • Regulatory Compliance Assessments • Reporting Tools • Senior Industry Experts • SOP Management • Project Management • Assessment Builder Tools • Marketing Services • CV Builder Tools Computer-Based Training Courses • Focus on Compliance, GMP, GCP • Employee Management and Leadership Content from CrossKnowledge • In-House Learning Services Team Supports Custom Course Development
  8. 8. Partnerships & Alliances
  9. 9. Unique Relationship with FDA • Exclusive CRADA between FDA’s Office of Regulatory Affairs (ORA) University and EduNeering – Renewed Through June 2014 • FDA goals: Ensure consistent enforcement of regulations, increase skill level and performance • FDA’s online university for 30,000 inspectors, ORA U, includes an online course curriculum developed with Kaplan EduNeering • All online courses are available to regulated industry
  10. 10. Exclusive Relationship with AdvaMed Exclusive Online Compliance Partner to AdvaMed GMP, GCP, Inspections & Enforcement, QSR curricula reviewed by AdvaMed is integral to alliance
  11. 11. Strategic Alliance with DIA Providing Online Education for Drug and Medical Device Professionals Good Clinical Practices (GCP) Managing Contract Research Organizations (CROs) Bioresearch Monitoring Safety & Adverse Event Reporting
  12. 12. Strategic Alliance with CrossKnowledge CrossKnowledge designs, develops and markets the most authoritative catalog, with more than 15,000 courses and tools that address all management and leadership topics. Harvard and many of the world’s other top business schools make up their faculty. More than two million managers, sales people and executives are trained each year.
  13. 13. Our Focus on Learning and Compliance Sales: “We need to educate our global sales and marketing teams on product knowledge.” Leadership Team: HR: “We need to provide “We need to provide management and orientation andperformance development ongoing employee opportunities.” training.” Quality Assurance: Compliance:“Has she been trained “We need to train all on her specific job employees and contractors function?” on Code of Conduct and other policies.”
  14. 14. SaaS Model Supports Multiple Communities
  15. 15. Built From the Ground Up SaaS Model • Kaplan EduNeering Owned and Managed Data Centers: – Reduced IT/Validation Effort – Reduced Deployment Time – Provide global learners and administrators with 24/7 access, from any internet connection – Immediate access to software enhancements – Ability to customize applications
  16. 16. Available & Reliable • Data centers in both Houston, TX and Princeton, NJ • 99.99+% uptime since 2005 • Redundant power and communications infrastructure from independent points of service • Redundant servers, routers, and firewalls • Redundant components such as hard drives, power supplies, and network cards • Six layers of data backup including offsite tape storage with Iron Mountain.
  17. 17. Our Proven Quality System• Fully Documented SDLC• Change Control• Document Management• Management Responsibility• Nonconformity Control –“Bug tracking” – Corrective and Preventative Action (CAPA)• Training –We use our own system• Audits – Over 200 audits – Continuous Improvement Process
  18. 18. Our Proven Deployment Process• Leveraging best practices in Knowledge Management processes from industry experience• Partnering with our clients to ensure that your business goals & requirements are defined, documented, and delivered• Gathering & integrating needs from various business organizations to drive a cohesive enterprise approach• Determining reporting & metrics needs that drive the configuration approach• Leveraging & supporting your validation team to deliver a validated and Part 11 compliant system• Incorporating change management & communications support throughout the deployment
  19. 19. Continuous State of Training & Development
  20. 20. The ROLES Based Training Formula • Review your training matrix • Organize you training into Curricula • Leverage User Groups • Employ Recurring Assignments • System Maintenance
  21. 21. ROLES : Review Your Training Matrix Company Corporate / Divisional Requirements Level Location Facility-Specific Level Dept Functional Knowledge Level Role Job-Specific Level
  22. 22. ROLES: Review Your Training Matrix OLES• Review what you have now (be honest)• Determine what is missing• Perform a risk based analysis• Start slow and build with consistency• Build you internal processes
  23. 23. ROLES: Organize training into Curricula O
  24. 24. ROLES: Organize Training Into Curricula O • Manageable Size • Curriculum Types • Due Dates / Retraining Periods • Sequencing • Define you process for maintaining curricula
  25. 25. ROLES: Leverage User Groups ES Each site receives its own security and administrative roles, while still being part of the entire company’s learning architecture.
  26. 26. ROLES: Leverage User Groups ES • User Groups - “Containers” for users - Labels / characterizes / groups common users - Populate via criteria whenever possible • Group Types and Group Type Hierarchy - Additional options for categorizing and creating relationships between User Group
  27. 27. ROLES Based Training Matrix Role-Based User Groups Role-Based Curricula Location Company Level Level Dept Role Level Level Recurring Assignment HR EDMS
  28. 28. ROLES : System Maintenance • Monitor the system through standardized reporting • Standardize nomenclature and other meta data • Create an assign Security Roles as appropriate • Decentralize system administration where and how it is appropriate • Maintain control of data entry and system usage through documented procedures and monitoring - Users, Training Items, Curricula, User Groups • This is an exercise in continuous improvement and there are many consolidation and refinement opportunities
  29. 29. ROLES: Qualification ReportingROLES
  30. 30. ROLES: Qualification ReportingROLES
  31. 31. ROLES: Compliance DashboardROLES
  32. 32. Managing Organizational Behavior and PerformanceDocumented Dashboards & Metrics Reduced risk ofobjective training non-compliancerequirements TargetedDocumented CV Resource Content Reduced Builder Planning (Visual Job Administrationobjective non- Aides, CBT…)ambiguous evidence Reduction inof Human Error Extended reach straining/qualification Redu nt Biometrics &Consistent Content MES & Other vemeimplementation of Single Sign Hosting Integrationstraining requirements On (SSO) ctionsacross rolesProactive, not Improved efficiency and value Added Return on Investment ImproReactive HRIS Interface E-Registration EDMSGlobal Visibility Sheet Interface & User Registration Base Implementation Training Matrix & ComplianceWire Recurring (with Dynamic Dates, CICS, Quiz Creator, Forms) Assignments
  33. 33. Let’s Take a Look!
  34. 34. The End of the “Project”… …but just the beginning of the partnership!
  35. 35. Platform Client ServicesConcierge Help DeskResponding quickly to customer inquiriesTechnical SupportThorough understanding of each unique technologyimplementation and configurationTrainingDriving best practices through proactive training
  36. 36. Platform Client ServicesKnowledgeable…All client service representatives are KaplanEduNeering staff, with extensive productknowledge, and several have real-worldComplianceWire experienceAvailable 24/7…All client service representatives haveblackberry and continuous computer accessaround the clock, to support a global workforceProactive…Our client services team distributes regularnewsletters and hosts webinars to assistsystem administrators with best practices andnew features
  37. 37. Our Global Response Process: During Business Hours (EST) During Non-Business Hours (EST) Full-time staff handles all Full-time staff on-call 24/7 global issues Calls through toll-Free Calls are routed to number are routed to first assigned representative available representative via Blackberry Centralized e-mail address E-mails are routed to ensures quick response assigned representative via home-based laptop
  38. 38. Additional Benefits of our Partnership• Quarterly Multi-Media Communications• User forums and events – Annual Knowledge Summit – Client Hosted Leaders in Life Science Seminars• Access to industry experts and thought leaders• Quarterly review meetings with Kaplan EduNeering Senior Leadership Team• Unique Insight into FDA best practices• FDA Audit Support Hotline

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