1. Solutions Overview:
Online Compliance
Training

2. Agenda
• About Us
• Our Partnerships
• Our Focus on Learning and Compliance
• Our Focus on Employee Performance
• Questions & Answer Period

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. 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. Breadth of Clients, Deep Life-Science Expertise

6. Key Differentiators

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. Partnerships & Alliances

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. Exclusive Relationship with AdvaMed
Exclusive Online Compliance
Partner to AdvaMed
GMP, GCP, Inspections &
Enforcement, QSR curricula reviewed
by AdvaMed is integral to alliance

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. 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. 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 and
performance 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. SaaS Model Supports Multiple Communities

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. 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. 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. 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. Continuous State of Training & Development

20. The ROLES Based Training Formula
• Review your training matrix
• Organize you training into Curricula
• Leverage User Groups
• Employ Recurring Assignments
• System Maintenance

21. ROLES : Review Your Training Matrix
Company Corporate / Divisional Requirements
Level
Location Facility-Specific
Level
Dept Functional Knowledge
Level
Role Job-Specific
Level

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. ROLES: Organize training into Curricula
O

24. ROLES: Organize Training Into Curricula
O
• Manageable Size
• Curriculum Types
• Due Dates / Retraining Periods
• Sequencing
• Define you process for maintaining curricula

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. 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. ROLES Based Training Matrix
Role-Based User Groups Role-Based Curricula
Location Company
Level Level
Dept Role
Level Level
Recurring Assignment
HR EDMS

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. ROLES: Qualification Reporting
ROLES

30. ROLES: Qualification Reporting
ROLES

31. ROLES: Compliance Dashboard
ROLES

32. Managing Organizational Behavior and
Performance
Documented Dashboards & Metrics
Reduced risk of
objective training non-compliance
requirements Targeted
Documented
CV Resource Content Reduced
Builder Planning (Visual Job Administration
objective non- Aides, CBT…)
ambiguous evidence Reduction in
of Human Error
Extended reach
s
training/qualification
Redu
nt
Biometrics &
Consistent Content MES & Other
veme
implementation of Single Sign
Hosting Integrations
training requirements On (SSO)
ctions
across roles
Proactive, not Improved efficiency and value Added Return on Investment
Impro
Reactive 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. Let’s Take a Look!

34. The End of the “Project”…
…but just the
beginning of the partnership!

35. Platform Client Services
Concierge Help Desk
Responding quickly to customer inquiries
Technical Support
Thorough understanding of each unique technology
implementation and configuration
Training
Driving best practices through proactive training

36. Platform Client Services
Knowledgeable…
All client service representatives are Kaplan
EduNeering staff, with extensive product
knowledge, and several have real-world
ComplianceWire experience
Available 24/7…
All client service representatives have
blackberry and continuous computer access
around the clock, to support a global workforce
Proactive…
Our client services team distributes regular
newsletters and hosts webinars to assist
system administrators with best practices and
new features

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. 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