Staying in compliance with a regulatory agency is stressful. It requires a level of attention to detail that is difficult, time-consuming and stressful. This session will walk through real-world examples of organizations like yours that rely on training to stay in compliance. You’ll see what steps they take to remain compliant and identify areas of concern. Whether your regulations are government-imposed or vendor requirements, being able to easily identify who requires training, who is at risk and who is late is critical. Don’t let spreadsheets, lack of resources and human error cause you to pay fines or, worse yet, shut your doors.

1. Compliance Training is Ruining My Business!
Speaker: Chris Lennon
Director of Product Management
SilkRoad technology Inc
Moderator: Daniel Margolis
Managing Editor
Chief Learning Officer magazine
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• Q&A
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3. Tools You Can Use
• Polling
– The poll will appear on the
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each question
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4. Frequently Asked Questions
1. Will I receive a copy of the slides after the webinar?
YES
2. Will I receive a copy of the webinar recording?
YES
Please allow up to 2 business days to receive these materials
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5. Compliance Training is Ruining My Business!
Daniel Margolis
Managing Editor
Chief Learning Officer magazine
#CLOwebinar

6. Compliance Training is Ruining My Business!
Chris Lennon
Director of Product Management
SilkRoad technology Inc
#CLOwebinar

7. Compliance Training
is Ruining My Business!
Presented by: Chris Lennon,
Director of Product Management
August 16th, 2011 2-3 PM EDT

8. We’re Proud to Say…
97% Renewal Rate 5 Million Users 62 of the Fortune 500
1500+ Customers Award-Winning Customer Service 80+ Countries
8

9. SilkRoad technology Life Suite
SilkRoad
offers
the
most
comprehensive
suite
of
talent
management
solu8ons
on
the
market.
Our
complete
suite
allows
human
resource
professionals
to
strengthen
and
personalize
employee
experiences
at
all
touch
touch
points

10. Introductions
o Who am I?
o Who are you?
o How compliance training can ruin your business.
10

11. Poll #1
o Where are you on the spectrum of compliance training?
o 1. Holy guacamole! We're supposed to be keeping track of
this stuff??
o 2. I'm so overwhelmed I want to curl up in a ball and hide
under my desk!
o 3. I'm fine until we have an audit - and my family will hate
being around me for a week.
o 4. No sweat, we have this thing licked… what's all the hubbub
about?
o 5. I'm only on here because I'm a CLO groupie
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12. Example #1
o January 2011 - Pharmaceutical company closed
o Deltex Pharmaceuticals Inc., of Rosenberg, TX
o U.S. Food and Drug Administration consent decree
o Prohibits manufacturing and distribution until compliant
o Violations of the Federal Food, Drug, and Cosmetic Act involving
manufacturing and distributing unapproved, adulterated, and
misbranded drugs.
o Recall and destroy drugs that were manufactured and distributed
since Oct. 31, 2008
o Penalties of $2,500 per day if fail to comply with consent decree
o Source: www.FDA.gov (http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm240272.htm)
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13. Example #2
o June – October 2010 – Charter Bus company shut down
o RLT Tours, LLC of Long Pond, PA
o U.S. Department of Transportation's Federal Motor
Carrier Safety Administration (FMCSA)
o Violations of federal safety regulations:
o Hours of service requirements for drivers
o Insurance requirements
o Vehicle maintenance standards
o Drug and alcohol testing compliance
o Source: pocononews.net (http://www.pocononews.net/news/2011/
February/24/24Feb11-2.html)
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14. Poll #2
o What drives your compliance training?
o 1. Federal Agency (HIPAA, 21 CFR Part 11, etc.)
o 2. Vendor Driven (equipment, tools, software, etc.)
o 3. HR – general legal (sexual harassment, ethics, etc.)
o 4. I don’t know, I’m just attending this webinar so my boss
thinks I’m busy.
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15. Gateway Computers
o Once the 4th largest computer
manufacturer in the world
o Large cow-spotted building
o Over 20,000 employees
o Over 280 locations
o Gateway brand still exists
o Export Regulations
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16. Gateway: Export Compliance
o Annual Export Compliance Training
o Company wide
o All sales and customer service staff trained
o Classroom Training and Paper Based Exam
o Tests created by legal / export department
o Tracked by spreadsheet
o Failed tests – schedule retake and make–up classes
o Hard copies filed for audit reference later
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17. Gateway: Lessons Learned
o Company wide initiatives are sometimes the most
efficient way to manage if an LMS is not in place
o Spreadsheets and filing cabinets are very difficult for
audit tracking
o Work with subject matter experts but have instructional
designers create the material and exams
o Verify wording is clear
o No trick questions
17

18. Gen-Probe Incorporated
o Global leader in development, manufacture & marketing
of Nucleic Acid Tests
o Diagnose infectious disease
o Screen donated human blood
o Ensure transplant compatibility
o NASDAQ: GPRO
o 1300 Employees
o San Diego Headquarters
18

19. Gen-Probe: Certification Training
o Training Needs
o Procedural (SOP)
o Hands – on proficiency component
o Employees trained once per SOP
o New Requirements
o Revisions
o Employees must be trained prior to
performing job

20. Gen-Probe: Training Administration
Before
After
50+ Database Admins
1 Administrator
20

21. Gen-Probe: SAGE
o Managers set requirements and monitor
o Compliance training assigned by:
o Job Title (core minimum requirements)
o Individual Inclusion/Exclusion (to customize)
o Org. Unit (company-wide requirements)
o Easy reporting
o Supervisor reports – assure employees are compliant
o Administrator reports – validation and accuracy
o Reports in the hands of an auditor within 60 seconds

22. Gen-Probe: Audits
o At least 14 audits since Jan 1, 2009
o Regulatory bodies (FDA / TUV - Europe)
o Partners
o Vendors
o Auditors like the LMS
o Immediate visibility
o Clean reporting
o LMS administrators run all requested
reports
o Filter out non-compliance based training
o Auditors provided paper copy
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23. Gen-Probe: Lessons Learned
o “Training is the glue that bonds the employee’s job description to what the employee
is actually doing.”
o Learning Management Systems are very helpful in managing compliance
o Be sure your system is flexible enough to accommodate your different certification cycles
o Never let employees fall out of compliance!
o Make sure employees know they are accountable for staying in compliance
o Involve management staff
o Let them take ownership
o Managerial level dictates what the employees need based on job title
o Provide easy to use tools to help them
o Partner with your Quality organization
o Don’t be afraid to ask why/why not when it comes to what compliance means
o Building the partnership helps assure the right thing is being done
o Smooth audits - everyone is on the same team
23

24. Children’s Memorial Hospital
o Chicago, IL
o Region’s top provider of pediatric
specialty care
o More than 146,000 children served
in 2010
o 1100 pediatric specialists
o 70 pediatric specialties
24

25. Children’s Memorial: Training
o Educational Requirements related
to patient safety
o Physicians
o Nurses
o Allied Health Staff
o Employees
o Computer based training modules
o Staff observation
o Mandated by regulatory agencies
o Joint Commission
o CMS
25

26. Children’s Memorial: The Numbers
o Approximately 3500 employees
complete compliance training
annually
o Approximately 20 compliance
courses per year
o Direct observation for about 1000
employees
o Excellent way to validate competence
o VERY time consuming
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27. Children’s Memorial: Initiatives
o Consistency within departments
o Standardized validation forms and
templates for competencies
o Ongoing process
o Implementing assessments to
allow employees to “test out” of
courses
27

28. Children’s Memorial: Lessons Learned
o Make sure program reflects organizational needs
o Make education easily accessible
o Have resources in place
to assist with questions
28

29. For More Information
o www.silkroad.com
o Gen-Probe case study
o SilkRoad.com > Resources
o www.Gen-Probe.com
o www.ChildrensMemorial.org
o Chris.Lennon@silkroad.com
o sales@silkroad.com to set up a personalized demo
29

30. 30

31. Question & Answer
Chris Lennon
Director of Product Management
SilkRoad technology Inc
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