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The Trickle Down Effect of
Compliance
January 29th, 2014
Liam Butler, General Manager EMEA
What we will discuss
 The importance of compliance

 Compliance and risk management requirements for L&D
 LMS complianc...
Compliance-oriented industries
Compliance in highly-regulated industries
1. Authenticity - validated identity authentication (e.g. esignatures or physica...
SHOW OF HANDS
How important is compliance training to your organisation?
 Not at all
 Slightly
 Moderately
 Very
 Cri...
How important is your organisation’s need to demonstrate
learning compliance to some external regulatory agency?
Overall

...
Preparedness is key
How prepared would you consider your organisation to be right now for a
compliance audit?
50%
45%

Hig...
SHOW OF HANDS
How is most of your organisation’s compliance training
delivered?
 Custom e-learning
 Classroom instructio...
How is compliance training
delivered?
Overall
4.1%

Learning Management System

8.8%

In-house developed system

6.4%
7.5%...
Compliance
 Compliance is the #1 driver within highly-regulated industries

 Comprehensive LMS functionality required:
...
Key regulations
 Aviation – EASA, CAA, TRTO, etc.
 Finance – FCA, RDR, CII, SOX, etc.
 Pharma – The GXPs (GLP, GMP, GCP...
What is compliance training?
Is it quality management?
 Compliance training is mandated training
 Often multiple sources...
Key principles of compliance
Compliance Training is part of a systematic approach for an organisation to prove
it is contr...
LMS compliance and quality
management features
 Security
 Hosting – infrastructure (the role of SaaS)
 User verificatio...
Modern trends in real-world
management of compliance
 Preparation: Plan for regulation specific requirements (such
as 21 ...
Pushing out compliance training
 Not common: Self enrollment

 Manager-based assignment
 Common: Administrator identifi...
Communicating requirements
to users
 Most Common Technique: Push out requirements to users
versus self enrollment (next s...
Monitoring compliance and
follow-up
 Common: Set deadlines/expiration: automatic email
notifications alert managers and a...
SHOW OF HANDS
Does your organisation conduct training gap analysis/risk
assessment for compliance?
 Yes
 No
 I don’t kn...
Compliance – the
impact of analytics
 CLIENT




Nuffield Health is the UK’s largest not for profit healthcare organis...
Why NetDimensions
Other Solutions

NetDimensions Talent Suite

Piecemeal collection of products

Organically developed, fu...
Our market focus
Our Market Focus – Compliance
Product portfolio – focused on compliance
How about non-compliance-oriented
businesses?
 Compliance covers a wide range of strategic and operational
needs in many ...
A few suggestions to make
compliance easier
1. Talk to your legal team and compliance officer to better
understand who is ...
QUESTIONS?
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Learning technologies 2014: The Trickle Down Effect of Compliance

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This presentation looks at how learning technologies and processes from highly regulated industries are filtering down to non compliance orientated businesses. We will focus on examples from Aviation and Life Sciences industries and how these can benefit the broader community.

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Learning technologies 2014: The Trickle Down Effect of Compliance

  1. 1. The Trickle Down Effect of Compliance January 29th, 2014 Liam Butler, General Manager EMEA
  2. 2. What we will discuss  The importance of compliance  Compliance and risk management requirements for L&D  LMS compliance and quality management features  Case studies – validating an LMS in the aviation, pharma & medical devices industries  How about non-compliance-oriented businesses?
  3. 3. Compliance-oriented industries
  4. 4. Compliance in highly-regulated industries 1. Authenticity - validated identity authentication (e.g. esignatures or physical identification) 2. Integrity - secure infrastructure (e.g. ISO 27001) 3. Confidentiality - data privacy & control (e.g. Secure SaaS) 4. Availability - system architecture (e.g. intrusion/DOS detection & prevention) 5. Auditability - tracking & reporting 6. Regulations (e.g. 21 CFR Part 11, EU GMP equivalent)
  5. 5. SHOW OF HANDS How important is compliance training to your organisation?  Not at all  Slightly  Moderately  Very  Critically
  6. 6. How important is your organisation’s need to demonstrate learning compliance to some external regulatory agency? Overall EMEA Not at all 10.2% Somewhat 11.6% Very Critical 40.4% 34.8% 23.5% 27.9% 25.9% Source: Brandon Hall Group: BHG, Compliance, 2012 N=399 25.6%
  7. 7. Preparedness is key How prepared would you consider your organisation to be right now for a compliance audit? 50% 45% High Performers 40% Low Performers 35% 30% 25% 20% 15% 10% 5% 0% Highly Prepared Source: Brandon Hall Group: BHG, Compliance, 2012 N=399 Very highly prepared
  8. 8. SHOW OF HANDS How is most of your organisation’s compliance training delivered?  Custom e-learning  Classroom instruction  Online simulations  Virtual classrooms
  9. 9. How is compliance training delivered? Overall 4.1% Learning Management System 8.8% In-house developed system 6.4% 7.5% 50.8% Paper-based system Content Management System 13.3% HR information system Incident tracking system 30.8% Source: Brandon Hall Group: BHG, Compliance, 2012 N=399 Other
  10. 10. Compliance  Compliance is the #1 driver within highly-regulated industries  Comprehensive LMS functionality required:  Access control and e-signatures  Tracking & auditing  Compliance reporting
  11. 11. Key regulations  Aviation – EASA, CAA, TRTO, etc.  Finance – FCA, RDR, CII, SOX, etc.  Pharma – The GXPs (GLP, GMP, GCP)  US FDA, e.g. 21 CFR Part 58, 210, 211, 820  EU GMP – 9 chapters & 20 annexes  UK Medicines & Healthcare Products Regulatory Agency (MHRA)  Data protection & local labour law
  12. 12. What is compliance training? Is it quality management?  Compliance training is mandated training  Often multiple sources for mandatory training  Internally mandated policy  Legislation  Mandated training has several actions  Courses, visual observations  Tests and exams  Documents that must be read and formally acknowledged in the case of Standard Operating Procedures (SOPs)  Compliance training must be documented  The completion of the training must be tracked and reported  The completion may be measured by attendance, progress through a course, test results, or a learner or supervisor’s signature (e-signature).
  13. 13. Key principles of compliance Compliance Training is part of a systematic approach for an organisation to prove it is controlling and recording a documented process in line with the regulations. 1. Say what you do  Have a written procedure that states what you do 2. Do what you say  Follow the procedure  If there is a deviation – write what was done  Do you need to revise the procedure? 3. Document it  Written or electronic evidence is needed to demonstrate that the procedure was followed
  14. 14. LMS compliance and quality management features  Security  Hosting – infrastructure (the role of SaaS)  User verification – tokens, IP address, etc.  Application security – vendor audit  Audit Trail  Evidence of behavior  E-Signatures  Certifications – exams, training & SOPs  Reporting & Analytics
  15. 15. Modern trends in real-world management of compliance  Preparation: Plan for regulation specific requirements (such as 21 CFR 21 Part 11)  Common management processes:     Step 1: Communicating Requirements to Users Step 2: Pushing Out Compliance Training Step 3: Monitoring Compliance and Follow-up Step 4: Optional validation and auditing
  16. 16. Pushing out compliance training  Not common: Self enrollment  Manager-based assignment  Common: Administrator identification and bulk/batch assignment.  Not Common: External Batch Assignment (perhaps file from external system)  Very Common: Rules-based Assignment (e.g. new employees with job title “Branch Manager”)  Very Common: Automated. For example, expiration of a certificate results in automatic new enrollment .
  17. 17. Communicating requirements to users  Most Common Technique: Push out requirements to users versus self enrollment (next slide)  Email Notifications (bulk direct, automated, rules based)  Graphical Learning Path  Multiple Implementation Strategies  Assign Individual Modules/Exams  Define Complex Programs (mandatory and optional blended learning)  Certifications for ease of tracking status and renewals, grace periods, etc.  Talent (Job Profiles/Competencies)
  18. 18. Monitoring compliance and follow-up  Common: Set deadlines/expiration: automatic email notifications alert managers and administrators  Most admins: Drill-down Analytics  Common: Ad-hoc and Regularly Scheduled (often weekly) reports distributed to managers  Common: Re-enroll automated handling versus email notification handling
  19. 19. SHOW OF HANDS Does your organisation conduct training gap analysis/risk assessment for compliance?  Yes  No  I don’t know
  20. 20. Compliance – the impact of analytics  CLIENT    Nuffield Health is the UK’s largest not for profit healthcare organisation 31 private hospitals, as well as a chain of fitness and well-being gyms in 200 locations in the UK Over 10,000 employees  CHALLENGE   Enterprise-wide risk management (“Automatic Compliance Engine”) Actionable compliance analytics based on individual employee risk profile  Automatically generated training plan custom to each employee  Notification alerts to employee & business line manager  Ongoing risk reporting to governance subcommittees and board stakeholders  RESULTS     Solution: NetDimensions Learning & NetDimensions Performance (SaaS) Differentiators: Configurability, continuous innovation, overall TCO De-facto risk & compliance management platform Four-fold increase in auto-enrolments in compliance training, cost savings of £465,000 yearly (based on streamlining learning)
  21. 21. Why NetDimensions Other Solutions NetDimensions Talent Suite Piecemeal collection of products Organically developed, fully integrated suite One-size-fits-all Fully configurable for a personalized user experience in 34 languages Monolithic, closed system Open architecture with public APIs & best-of-breed integrations Inability to scale in complex environments Ideal for highly regulated industries with both on premise and secure SaaS options Limited mobile capabilities Comprehensive mobile offering including on tablets & smartphones Hidden ongoing costs => low customer satisfaction “No client left behind” pledge
  22. 22. Our market focus
  23. 23. Our Market Focus – Compliance
  24. 24. Product portfolio – focused on compliance
  25. 25. How about non-compliance-oriented businesses?  Compliance covers a wide range of strategic and operational needs in many types of businesses.  Many of the techniques related to compliance also apply to simple “business requirements” management in nonregulated industries.  Automated management really does help in resource constrained or widely dispersed organisations!
  26. 26. A few suggestions to make compliance easier 1. Talk to your legal team and compliance officer to better understand who is responsible and what. 2. Define clear requirements and objectives for the training and LMS implementation. 3. Question your vendor and demand a software validation for the LMS. 4. Make compliance an on-going part of your business via welldefined workflows
  27. 27. QUESTIONS?

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