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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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                                                             #CLOwebinar
Compliance Training is Ruining My Business!




                     Daniel Margolis
                     Managing Editor
                     Chief Learning Officer magazine




                                         #CLOwebinar
Compliance Training is Ruining My Business!



                   Chris Lennon
                   Director of Product Management
                   SilkRoad technology Inc




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

o  Who am I?

o  Who are you?

o  How compliance training can ruin your business.




                            10
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




                                  11
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)



                                  12
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)



                                    13
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.




                                  14
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




                                   15
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




                                   16
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
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
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
Gen-Probe: Training Administration

      Before

                               After




50+ Database Admins


                           1 Administrator


                      20
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
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



            22
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
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
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
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


                 26
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
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
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
Question & Answer



      Chris Lennon
      Director of Product Management
      SilkRoad technology Inc




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8.16 tm silk_road_finalslides

  • 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 #CLOwebinar
  • 2. Tools You Can Use •  Q&A –  Click on the Q&A panel (?) in the bottom right corner –  Type in your question in the space provided –  Click on “Send.” #CLOwebinar
  • 3. Tools You Can Use •  Polling –  The poll will appear on the right side of your screen –  Select the best option for each question –  Click on “Submit” #CLOwebinar
  • 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 #CLOwebinar
  • 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 11
  • 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) 12
  • 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) 13
  • 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. 14
  • 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 15
  • 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 16
  • 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 22
  • 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 26
  • 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 #CLOwebinar
  • 32. Join Our Next CLO Webinar Fostering Learning Beyond the Classroom Thursday, August 25, 2011 CLO Webinars start at 2 p.m. Eastern / 11 a.m. Pacific www.clomedia.com/events http://network.clomedia.com/ #CLOwebinar