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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.
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Speaker: Chris Lennon Director of Product Management SilkRoad technology Inc
Moderator: Daniel Margolis
Managing Editor Chief Learning Officer magazine
Compliance Training is Ruining My Business!
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Daniel Margolis Managing Editor Chief Learning Officer magazine
Compliance Training is Ruining My Business!
#CLOwebinar
Chris Lennon Director of Product Management SilkRoad technology Inc
Compliance Training is Ruining My Business!
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…
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97% Renewal Rate 5 Million Users 62 of the Fortune 500
80+ Countries Award-Winning Customer Service 1500+ Customers
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.
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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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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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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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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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Gateway Computers
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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
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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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
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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
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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
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1 Administrator
Before
After
50+ Database Admins
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
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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
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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
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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
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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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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
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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
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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 [email protected] o [email protected] to set up a personalized demo
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Question & Answer
Chris Lennon Director of Product Management SilkRoad technology Inc
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