EduNeering Online Compliance Training Solutions Overview: Life Science
Solutions Overview:Online ComplianceTraining
Agenda • About Us • Our Partnerships • Our Focus on Learning and Compliance • Our Focus on Employee Performance • Questions & Answer Period
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
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
Breadth of Clients, Deep Life-Science Expertise
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
Exclusive Relationship with AdvaMed Exclusive Online Compliance Partner to AdvaMed GMP, GCP, Inspections & Enforcement, QSR curricula reviewed by AdvaMed is integral to alliance
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
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.
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.”
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
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.
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
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
The ROLES Based Training Formula • Review your training matrix • Organize you training into Curricula • Leverage User Groups • Employ Recurring Assignments • System Maintenance
ROLES : Review Your Training Matrix Company Corporate / Divisional Requirements Level Location Facility-Specific Level Dept Functional Knowledge Level Role Job-Specific Level
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
ROLES: Organize Training Into Curricula O • Manageable Size • Curriculum Types • Due Dates / Retraining Periods • Sequencing • Define you process for maintaining curricula
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.
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
ROLES Based Training Matrix Role-Based User Groups Role-Based Curricula Location Company Level Level Dept Role Level Level Recurring Assignment HR EDMS
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
The End of the “Project”… …but just the beginning of the partnership!
Platform Client ServicesConcierge Help DeskResponding quickly to customer inquiriesTechnical SupportThorough understanding of each unique technologyimplementation and configurationTrainingDriving best practices through proactive training
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
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
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