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Leverage Learning Technologies to Meet Your Compliance Regulations Facilitator: Bryan Chapman Chief Learning Strategist Chapman Alliance [email protected] Sponsored by: FDA SEC EPA OSHA SOX
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Leverage Learning Technologies to Meet Your Compliance Regulations
Facilitator:
Bryan ChapmanChief Learning Strategist
Chapman [email protected]
Sponsored by:
FDA
SEC
EPA
OSHA
SOX
I’m not going to talk about…
History of compliance and regulatory requirements
Recent fines and penalties (you can easily look these up)
The benefits of adhering to compliance standards
…or any other background information
Rather, let’s jump into some actionable steps and recommendations for leveraging learning technologies!
Where are you in the process?
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
CFR, Part 11
CFR, Part 11 regulation
Validation (consistent process, repeatable)
Accurate Reporting
Archival Protection of Records
Computer-Generated, Time-Stamped Audit Trail
Controls over Documentation (well established process over document distribution and sign off)
Electronic Signature System to determine that persons have “education, training, and experience to perform their assigned tasks”
Signatures can either be…
Hand Written
Biometric
Digital Signature
Learning Management System
LMS
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
Learning Management System
LMS
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
Learning Management System
LMS
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
Where are you in the process?
Polling Question
Which components of a learning infrastructure do you already have in place?
Learning Management System
LMS
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
Components
Off-the-shelf, pre-built courses
Virtual Classroom - Synchronous Learning
Self-Paced, Self-Service Online Learning
Informal Learning, Knowledge On Demand
Authoring Tools
Learning Management System
Learning Content Management
0% 10% 20% 30% 40% 50% 60%
43%
36%
45%
18%
55%
43%
18%
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 behaviors
4. Avoiding document misfiling that may result from human error
Advantages listed right in the document:
Assessing Competencies
Gap Analysis 40 Technical Skills
Gap Analysis
Gap Analysis
Where are you in the process?
Polling Question
Is your organization currently doing gap analysis?
Yes. In both Training and HR
Yes. In HR only
Yes. In Training only
No, or not much HR
Training
Gap Analysis Approach
14%4%
21%
61%
Yes. In both Training and HR
Yes. In HR only
Yes. In Training only
No, or not much
Does the word “competency” mean the same thing to both groups?
New CompanyHuman Resources
Radiology Technician: Operates X-ray equipment Good people/patient skills Practice patient safety Teamwork/Collaboration
Radiology Technician: Follows correct procedure to calibrate X-
ray equipment Practices seven steps to mixing chemicals
without endangering patients When encountering a difficult patient,
practices proper engagement strategy
Training
Learning Management System
LMS
Regulatory Compliance – Maturity Model
Level Description
Level 0 Limited understanding of compliance requirements, poorly managed record keeping (of any kind)
Level 1 Paper-based documentation with “read and understood” (handwritten or electronic signature)
Level 2 Electronically delivered documentation with “read and understood” (electronic signature)
Level 3 Electronic delivery with knowledge-based assessment of learning
Level 4 Electronic delivery with assessment and on-the-job practicum
Level 5 Electronic delivery with assessment, practice in safe environment (simulation), on-the-job practicum, and part of performance appraisal
Good
Better
Best
Where are you in the process?
Polling Question
What level are you at in the regulatory-compliance maturity model?
Level Description
Level 0 Limited understanding of compliance requirements, poorly managed record keeping (of any kind)
Level 1 Paper-based documentation with “read and understood” (handwritten or electronic signature)
Level 2 Electronically delivered documentation with “read and understood” (electronic signature)
Level 3 Electronic delivery with knowledge-based assessment of learning
Level 4 Electronic delivery with assessment and on-the-job practicum
Level 5 Electronic delivery with assessment, practice in safe environment (simulation), on-the-job practicum, and part of performance appraisal
Regulatory Maturity
Level 0 - None
Level 1 - Read and Understood
Level 2 - Electronic Signatures
Level 3 - Read and Test
Level 4 - Read, Test, and OJT
Level 5 - Read, Test, Simulation, and OJT
0% 5% 10% 15% 20% 25% 30%
0%
18%
29%
29%
18%
7%
Blended Learning
Safety information
Standard Operating Procedures
PowerPoint
Word
GXP
Role Play Simulations
Lab Simulations
SelfAssessment
Practice
on-the-job“culminating experience”
on-the-job“culminating experience”
HIPAA
Blended Learning
Safety information
Standard Operating Procedures
PowerPoint
Word
GXP
Role Play Simulations
Lab Simulations
SelfAssessment
Practice
on-the-job“culminating experience”
on-the-job“culminating experience”
HIPAA
Bloom’s Taxonomy
• Knowledge Action verbs: list, define, tell, describe, identify, show, label, collect,
examine, tabulate, quote, name, who, when, where, etc.
• Comprehension Action verbs: summarize, describe, interpret, contrast, predict, associate,
distinguish, estimate, differentiate, discuss, extend, etc.
• Application Action verbs: apply, demonstrate, calculate, complete, illustrate, show,
solve, examine, modify, relate, change, classify, experiment, discover, etc.
• Analysis Action verbs: analyze, separate, order, explain, connect, classify, arrange,
divide, compare, select, explain, infer, etc.
• Synthesis Action verbs: combine, integrate, modify, rearrange, substitute, plan,
create, design, invent, what if?, compose, formulate, prepare, generalize, rewrite, etc.
• Evaluation Action verbs: assess, decide, rank, grade, test, measure, recommend,
convince, select, judge, explain, discriminate, support, conclude, compare, summarize, etc.
Pilot Training
Step 1: Ground School
Step 2:Simulator
Step 3: Fly with a Mentor
Step 4: Fly alone
Facts, ConceptsProcedures
Application More Application, Analysis, Synthesis and Evaluation
Same, with little or no guidance
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
their jobs… General industry experience would not necessarily prepare someone to begin
specific, highly technical tasks at a given firm. Some degree of on-the-job training would be
customary and expected. The agency believes that documentation of such training is also
customary and not unreasonable.”
…determine that persons have “education, training, and experience to perform their assigned tasks”
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
their jobs… General industry experience would not necessarily prepare someone to begin
specific, highly technical tasks at a given firm. Some degree of on-the-job training would be
customary and expected. The agency believes that documentation of such training is also
customary and not unreasonable.”
…determine that persons have “education, training, and experience to perform their assigned tasks”How do we
define “sufficient”?
Reactive vs. Proactive compliance
Reactive Proactive
• Meet only standard minimum requirements
• Show a movie during a company meeting
• Teach “boring“ material isolation
• Quick “read and understood” signoff
• Regulatory and compliance training is mostly “read”
• Use regulatory compliance as a teaching opportunity
• Emergency simulation (i.e. fire safety)
• Integrate into other teaching and learning activities
• Link with on-the-job training assignments
• Regulatory and compliance training is mostly “experienced”
Learning Management System
LMS
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
What about tacit knowledge?
ExplicitKnowledge
Tacit Knowledge
• Identifying is difficult• Documenting is even
more difficult
Informal LearningPfizerpedia
Questions???
Facilitator:
Bryan ChapmanChief Learning Strategist
Chapman [email protected]
Sponsored by:
FDA
SEC
EPA
OSHA
SOX
White Paper
