proactive vs. reactive: a new level of maturity for
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November 10 - 13, 2009 San Jose, CA
Page 1
Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
Proactive vs. Reactive: A New Level of Maturity for Compliance and
Regulatory Training
Facilitator:
Bryan ChapmanChief Learning Strategist
Chapman Alliancebryan@chapmanalliance.com
Polling Question
Which regulatory requirement documents have you actually read? (check all that apply)
21 CFR, Part 11
HIPAA
OSHA (29 CFR)
ISO 9000
Sarbanes-Oxley (SOX)
Other (which ones)
None of these
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
CFR, Part 11
CFR, Part 11 regulation
Validation (consistent process, repeatable)
Accurate ReportingArchival Protection of RecordsComputer-Generated, Time-Stamped Audit TrailControls over Documentation (well established process over document distribution and sign off)Electronic Signature System to determine that persons have “education, training, and education, training, and experience to perform their assigned experience to perform their assigned taskstasks”
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
Signatures can either be…
Hand Written
Biometric
Digital Signature
Learning Management SystemLMS
Virtual ClassroomSynchronous Learning
Self-Paced, Self-Service Online Learning
Informal Learning, Knowledge On Demand
Off-the-shelf, pre-built courses
Authoring Tools
Learning Content Management
• Ready-to-use content (courseware)• Easy to find: IT skills, leadership, safety• Hard to find: very specific, job-related skills
• Custom development• Screen design and layout• Interactive exercises• Tests, Quiz, Assessment• Simulations
• Manage large-scale development (workflow)
• Reusable learning content• Searchable repository of source
material
• Central Access to Learning• Individualized Learning Plans• Reporting & Completion Tracking• Instructor-Led Training Scheduling• Launch and track online learning• Certification Management• Competency Management• Skill Gap Analysis• Archiving records• Automating Digital Signatures
• Instructor-led, Real time, Online• Connecting geographical disperse
learners• Groups of learners meet together
• 24 X 7 X 365 access to courses• Completed at learner’s own pace• Remediation and feedback are
automated• Developed once, used many times• Automated scoring and completion
status
• Just-in-time, anywhere, anytime• Capture and retain organizational
knowledge• Facilitates collaboration
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
Polling Question
Which components of a learning infrastructure do you already have in place?
Learning Management SystemLMS
Virtual ClassroomSynchronous Learning
Self-Paced, Self-Service Online Learning
Informal Learning, Knowledge On Demand
Off-the-shelf, pre-built courses
Authoring Tools
Learning Content Management
CFR, Part 11 favors electronic vs. paper delivery
1. Advanced Search of Information (eliminating search of manual records)
2. Permitting information to be viewed from multiple perspectives
3. Identifying trends, patterns and behaviors4. Avoiding document misfiling that may result from
human error
Advantages listed right in the document:
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
Assessing Competencies
Gap Analysis40 Technical Skills
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
Regulatory requirement = blended learning
“The agency regards this requirement as fundamental to the proper operation of a facility. Personnel entrusted with important functions must have sufficient training to do sufficient training to do
their jobstheir jobs… General industry experience would not necessarily prepare someone to begin
specific, highly technical tasks at a given firm. Some degree of onon--thethe--job training would be job training would be
customary and expectedcustomary and expected. The agency believes that documentationdocumentation of such training is also
customary and not unreasonable.”
…determine that persons have “education, training, and education, training, and experience to perform their assigned tasksexperience to perform their assigned tasks”How do we
define “sufficient”?
Reactive vs. Proactive compliance
November 10 - 13, 2009 San Jose, CA
Page 12
Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
Learning Management SystemLMS
Virtual ClassroomSynchronous Learning
Self-Paced, Self-Service Online Learning
Informal Learning, Knowledge On Demand
Off-the-shelf, pre-built courses
Authoring Tools
Learning Content Management
• Ready-to-use content (courseware)• Easy to find: IT skills, leadership, safety• Hard to find: very specific, job-related skills
• Custom development• Screen design and layout• Interactive exercises• Tests, Quiz, Assessment• Simulations
• Manage large-scale development (workflow)
• Reusable learning content• Searchable repository of source
material
• Central Access to Learning• Individualized Learning Plans• Reporting & Completion Tracking• Instructor-Led Training Scheduling• Launch and track online learning• Certification Management• Competency Management• Skill Gap Analysis• Archiving records• Automating Digital Signatures
• Instructor-led, Real time, Online• Connecting geographical disperse
learners• Groups of learners meet together
• 24 X 7 X 365 access to courses• Completed at learner’s own pace• Remediation and feedback are
automated• Developed once, used many times• Automated scoring and completion
status
• Just-in-time, anywhere, anytime• Capture and retain organizational
knowledge• Facilitates collaboration
Informal Learning
“Informal learning is simply that, which is not directed by an organization or somebody in a
control position.”
- Jay Cross
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
What about tacit knowledge?
ExplicitKnowledge
Tacit Knowledge
• Identifying is difficult• Documenting is even
more difficult
Informal Learning
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
User Generated Content (UGC) Matrix
Summary – Call to Action
Develop a “proactive” strategy for regulatory-compliance training. Do more than meet minimum requirementsBlended learning is the key. Use all types of tools including off-the-shelf courses, simulations, and engaging on-the-job training to …determine that persons have “education, training, and education, training, and experience to perform their assigned experience to perform their assigned taskstasks”Use informal learning to leverage the knowledge of your team, but be cautious of its direct use in compliance settings.
November 10 - 13, 2009 San Jose, CA
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Session 413 – Proactive vs. Reactive: A New Level of Maturity for Compliance and Regulatory Training – Bryan Chapman, Chapman Alliance
White Paper
Questions???
Facilitator:
Bryan ChapmanChief Learning Strategist
Chapman Alliancebryan@chapmanalliance.com
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