Sponsored by:
Leverage Learning
Technologies to Meet Your
Compliance Regulations
Facilitator:
Bryan Chapman
Chief Learning Strategist
Chapman Alliance
[email protected]
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!
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
Polling Question
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
Off-the-shelf,
pre-built courses
Virtual Classroom
Synchronous Learning
• Instructor-led, Real time, Online
• Connecting geographical disperse
learners
• Groups of learners meet together
• Ready-to-use content (courseware)
• Easy to find: IT skills, leadership, safety
• Hard to find: very specific, job-related skills
Self-Paced, Self-Service
Online Learning
Authoring Tools
•
•
•
•
•
Custom development
Screen design and layout
Interactive exercises
Tests, Quiz, Assessment
Simulations
Learning Content
Management
• Manage large-scale development
(workflow)
• Reusable learning content
• Searchable repository of source
material
Learning Management
System
LMS
•
•
•
•
•
•
•
•
•
•
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
• 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
Informal Learning,
Knowledge On Demand
• Just-in-time, anywhere, anytime
• Capture and retain organizational
knowledge
• Facilitates collaboration
Off-the-shelf,
pre-built courses
Virtual Classroom
Synchronous Learning
• Instructor-led, Real time, Online
• Connecting geographical disperse
learners
• Groups of learners meet together
• Ready-to-use content (courseware)
• Easy to find: IT skills, leadership, safety
• Hard to find: very specific, job-related skills
Self-Paced, Self-Service
Online Learning
Authoring Tools
•
•
•
•
•
Custom development
Screen design and layout
Interactive exercises
Tests, Quiz, Assessment
Simulations
Learning Content
Management
• Manage large-scale development
(workflow)
• Reusable learning content
• Searchable repository of source
material
Learning Management
System
LMS
•
•
•
•
•
•
•
•
•
•
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
• 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
Informal Learning,
Knowledge On Demand
• Just-in-time, anywhere, anytime
• Capture and retain organizational
knowledge
• Facilitates collaboration
Off-the-shelf,
pre-built courses
Virtual Classroom
Synchronous Learning
• Instructor-led, Real time, Online
• Connecting geographical disperse
learners
• Groups of learners meet together
• Ready-to-use content (courseware)
• Easy to find: IT skills, leadership, safety
• Hard to find: very specific, job-related skills
Self-Paced, Self-Service
Online Learning
Authoring Tools
•
•
•
•
•
Custom development
Screen design and layout
Interactive exercises
Tests, Quiz, Assessment
Simulations
Learning Content
Management
• Manage large-scale development
(workflow)
• Reusable learning content
• Searchable repository of source
material
Learning Management
System
LMS
•
•
•
•
•
•
•
•
•
•
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
• 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
Informal Learning,
Knowledge On Demand
• Just-in-time, anywhere, anytime
• Capture and retain organizational
knowledge
• Facilitates collaboration
Which components of a learning
infrastructure do you already have in
place?
Off-the-shelf,
pre-built courses
Virtual Classroom
Synchronous Learning
Authoring Tools
Learning Management
System
Self-Paced, Self-Service
Online Learning
LMS
Learning Content
Management
Informal Learning,
Knowledge On Demand
Polling Question
Components
18%
Learning Content Management
43%
Learning Management System
55%
Authoring Tools
18%
Informal Learning, Knowledge On Demand
45%
Self-Paced, Self-Service Online Learning
36%
Virtual Classroom - Synchronous Learning
43%
Off-the-shelf, pre-built courses
0%
10%
20%
30%
40%
50%
60%
CFR, Part 11 favors electronic vs. paper delivery
Advantages listed right in the document:
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
Assessing Competencies
Gap Analysis
 40 Technical Skills 
Gap Analysis
Gap Analysis
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
Polling Question
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?
Human Resources
New Company
Training
Learning
Management System
LMS
Radiology Technician:
Radiology Technician:
 Operates X-ray equipment
 Follows correct procedure to calibrate Xray equipment
 Good people/patient skills
 Practice patient safety
 Teamwork/Collaboration
 Practices seven steps to mixing chemicals
without endangering patients
 When encountering a difficult patient,
practices proper engagement strategy
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
Good
Level 4
Better
Level 5
Best
Electronic delivery with assessment and on-the-job
practicum
Electronic delivery with assessment, practice in safe
environment (simulation), on-the-job practicum, and part
of performance appraisal
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
Polling Question
Regulatory Maturity
7%
Level 5 - Read, Test, Simulation, and OJT
18%
Level 4 - Read, Test, and OJT
Level 3 - Read and Test
29%
Level 2 - Electronic Signatures
29%
18%
Level 1 - Read and Understood
0%
Level 0 - None
0%
5%
10%
15%
20%
25%
30%
Blended Learning
Safety information
HIPAA
on-the-job
“culminating
experience”
Self
Assessment
Word
Lab
Simulations
.PDF
Practice
PowerPoint
GXP
Role Play
Simulations
Standard Operating Procedures
Blended Learning
Safety information
HIPAA
on-the-job
“culminating
experience”
Self
Assessment
Word
Lab
Simulations
.PDF
Practice
PowerPoint
GXP
Role Play
Simulations
Standard Operating Procedures
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,
Concepts
Procedures
Application
More
Application,
Analysis,
Synthesis
and
Evaluation
Same, with
little or no
guidance
Regulatory requirement = blended learning
…determine that persons have “education, training, and
experience to perform their assigned tasks”
“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.”
Regulatory requirement = blended learning
How do we
define
“sufficient”?
…determine that persons have “education, training, and
experience to perform their assigned tasks”
“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.”
Reactive vs. Proactive compliance
Reactive
Proactive
•
Meet only standard minimum
requirements
•
Use regulatory compliance as
a teaching opportunity
•
Show a movie during a
company meeting
•
Emergency simulation (i.e. fire
safety)
•
Teach “boring“ material
isolation
•
Integrate into other teaching
and learning activities
•
Quick “read and understood”
signoff
•
Link with on-the-job training
assignments
•
Regulatory and compliance
training is mostly “read”
•
Regulatory and compliance
training is mostly
“experienced”
Off-the-shelf,
pre-built courses
Virtual Classroom
Synchronous Learning
• Instructor-led, Real time, Online
• Connecting geographical disperse
learners
• Groups of learners meet together
• Ready-to-use content (courseware)
• Easy to find: IT skills, leadership, safety
• Hard to find: very specific, job-related skills
Self-Paced, Self-Service
Online Learning
Authoring Tools
•
•
•
•
•
Custom development
Screen design and layout
Interactive exercises
Tests, Quiz, Assessment
Simulations
Learning Content
Management
• Manage large-scale development
(workflow)
• Reusable learning content
• Searchable repository of source
material
Learning Management
System
LMS
•
•
•
•
•
•
•
•
•
•
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
• 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
Informal Learning,
Knowledge On Demand
• 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?
Tacit
Knowledge
• Identifying is difficult
• Documenting is even
more difficult
Explicit
Knowledge
Informal Learning
Pfizerpedia
Sponsored by:
Questions???
Facilitator:
Bryan Chapman
Chief Learning Strategist
Chapman Alliance
[email protected]
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