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2Copyright © Veeva Systems 2020
Disclaimer
This presentation is for informational purposes only and does not
constitute legal or other professional advice. You should consult your
own legal or compliance team before making a compliance decision.
All information is provided “as is”, with no guarantee of completeness,
accuracy, timeliness or of the results obtained from the use of this
information, and without warranty of any kind, express or implied. In
no event will Veeva be liable to you or anyone else as a result of your
use on this information.
3Copyright © Veeva Systems 2020
John Constantine
ORCHESTRALL
John is a veteran of over 30 years in the life
sciences industry, first at GlaxoSmithKline, then
at Merck as Executive Director, Merck
Polytechnic Institute in 2008, and joining
Orchestrall, Inc. as Senior VP, Learning & Talent
Solutions in 2016. His background includes
Sales, Marketing, Corporate Staffs, Information
Technology, Research and Development, and 25
years in Learning & Development.
VEEVA SYSTEMS
Kent has spent the majority of his career
delivering technology-enabled training solutions
to life sciences, holding leadership positions at
industry leading companies such as AdMed,
ClearPoint (Red Nucleus), UL EduNeering (UL),
and now Veeva Systems.
Kent Malmros
GxP Training
Then and Now
5Copyright © Veeva Systems 2020
GxP Training Then: Traditional Approaches
Document-Centric
Training on key policies and procedures as documented
to standard templates, then authored, reviewed and
approved in governed workflows.
eLearning Libraries
Content built around FDA guidelines specific to key GxP
topics (Good Manufacturing Practices, etc.) that are key
to remaining compliant.
Macro-Learning
Documents, eLearning or classroom training all based
on multiple learning objectives built for instruction
over large periods of time (one hour or more).
6Copyright © Veeva Systems 2020
GxP Training Now: Modernization
Engagement
Retain learner interest
Storytelling opportunity
Flexible approaches
Device-friendly
Competency
Over completion
Focused behavior
Reinforcement
Videos
SOP replacement
Work instructions
Reference materials
Microlearning
an Exploration
8Copyright © Veeva Systems 2020
Microlearning is an instructional unit that
provides a short engagement in an activity
intentionally designed to elicit a specific
outcome from the participant.
- Microlearning: Short and Sweet.
Karl Kapp and Roby DeFelice
9Copyright © Veeva Systems 2020
I can’t afford to make a lot of videos.
Microlearning is not exclusively about video
We don’t know how to change our approach.
Don’t change, enhance your approach.
Does your platform “have microlearning”
Microlearning is not software
Demystifying Microlearning
What we hear everyday on the ground,
makes it inaccessible to GxP trainers
10Copyright © Veeva Systems 2020
The Case for Microlearning
As part of modernization
It works. Science
demonstrates that the
framework is valid.
Fits with modernizing
concepts of Quality 4.0
and training
Growing industry
adoption and
understanding
11Copyright © Veeva Systems 2020
We already use it
Poll Question:
What is your organization’s position on
microlearning?
We already use it, but not as part of GxP Training
We don’t use it, but plan to in the next 12 months
We don’t use it, and currently have no plans to
12Copyright © Veeva Systems 2020
Data Supporting Microlearning
12% 85%
Sustained higher knowledgeIncrease in knowledge
2018 Microlearning Global Benchmark Report. Axonify
13Copyright © Veeva Systems 2020
What Microlearning is NOT
Learning strategy considerations Curriculum design considerations
NEW
“Shrunken head” learning
Right for every learning outcome
About knowledge
A complete learning ecosystem
A resource library
Wholesale replacement for other
learning initiatives
Microlearning: Short and Sweet by Robyn A. Defelice, Karl M. Kapp
September 2019
14Copyright © Veeva Systems 2020
Defining Microlearning
As part of modernization
Microlearning Macro-Learning
• I need help now • I want to learn something new
• 2-15 minutes • Several hours or days
• Declarative, conceptual knowledge • Problem solving, procedures, interpersonal skills
• Search by asking a question • Content guided by others
• Multiple modalities (video trending) • Multiple modalities (traditional eLearning or ILT)
• Indexed and searchable • Coaching and support needed
• Content rated for quality utility • Content consumed when delivered
• Refresher learning • Deeper learning, building meaning
• Videos, articles, code samples, job aids • Courses, classes, MOOCs, programs
Microlearning: Short and Sweet by Robyn A. Defelice, Karl M. Kapp
September 2019
15Copyright © Veeva Systems 2020
Common Microlearning Principles
Size
The most discussed attribute of
microlearning is the shorter
duration of learner seat time
for training materials.
Reinforcement
Shorter materials mean easier
opportunities for use beyond
prescriptive assignments,
which encourages re-use.
Quizzing
Less content can mean shorter,
more targeted quizzes to
ensure comprehension or
competency on key topics.
Video
Microlearning is often thought
to be a video-based modality;
while it’s not, video is often a
popular approach.
Creation
Fewer resources may be
necessary to build a micro-
learning asset, but more
strategy is required.
Delivery
The type of microlearning you
develop should take your
delivery method into
consideration.
16Copyright © Veeva Systems 2020
Defining Microlearning
Five “Types” of Microlearning
Primary PersuasivePost-
Instruction
Performance
SupportPreparatory
Microlearning: Short and Sweet by Robyn A. Defelice, Karl M. Kapp
September 2019
17Copyright © Veeva Systems 2020
The Science Behind Microlearning
Spacing of
Key Content
Avoiding Cognitive
Overload
Repetition and
Reinforcement
Zambito, Victor. (2018) The Brain Science of Microlearning: Why It Works.
https://trainingindustry.com/articles/content-development/the-brain-science-of-microlearning-why-it-works/
18Copyright © Veeva Systems 2020
Data Supporting Microlearning
50% 50%
More
engagement
Reduction in
development costs
Gutierrez, Karla (2018) Numbers Don’t Lie: Why Microlearning is Better for Your Learners (and You too)
https://www.shiftelearning.com/blog/numbers-dont-lie-why-bite-sized-learning-is-better-for-your-learners-and-you-too
19Copyright © Veeva Systems 2020
Microlearning
for GxP
20Copyright © Veeva Systems 2020
Making it engaging
Poll Question:
What are the biggest challenges you
have with your GxP training program?
Demonstrating competency
Resource constraints
Lack of executive support
21Copyright © Veeva Systems 2020
Growing Beyond GxP Training
Shifting the emphasis beyond GxP and Quality
True Digital Modified Objectives Media-centric Data Cleansing
Microlearning
drives the push away
from “paper”
Tailor learning objectives
to meet smallest possible
”need”
Consider any and every
opportunity to replace
documents with
multimedia
Opportunity to “weed”
out old materials when
re-factoring
22Copyright © Veeva Systems 2020
Microlearning as a Complement
Focus RiskOperation
R&D I MEDICAL I COMMERCIAL
23Copyright © Veeva Systems 2020
Examples of Applicable Microlearning
SOP
Replacement
Why must SOPs be
documents? Break up a
procedure into smaller
ones and then building
corresponding learning
assets
Delta
Training
With existing dense
documents, sending a
revised SOP for training
doesn’t convey changes;
build a short slide or
image to train
Quick Reference
Guides
Summarizing a
document in acceptable
to augment GxP training;
this can be done in any
format that makes sense
Video Work
Instructions
Developing shorter
video-based work
instructions encourages
just-in-time use of
learning assets as
ongoing reference
materials
24Copyright © Veeva Systems 2020
Specific Recommendations for GxP Microlearning
SITE-BASED
FLASH CARDS
AR-BASED
PERFORMANCE
SUPPORT
SPACED
KNOWLEDGE
CHECKS
DIGITAL
JOB AIDS
SINGLE
PROCEDURE
VIDEOS
25Copyright © Veeva Systems 2020
Customer Use Case
West coast emerging Biotech
Shift away from traditional SOP training
Revised learning strategy
Variety of small assets to support learning
objectives
Desire for 21st century feel
US, EU, ASIA
STAFF
HUGE
CLINICAL
TRIAL BASE
1200
EMPLOYEES
$7.3B
IN REVENUE
26Copyright © Veeva Systems 2020
Customer Use Case Outcomes
App launched for company/personal
devices to 210 clinical staff
>5000 interactions in 6 months (all ”pull”)
Uses:
• Important management comms
• Safety training (primary)
• Follow up reinforcement
• SOP chatbot pilot (AI-driven)
US, EU, ASIA
STAFF
HUGE
CLINICAL
TRIAL BASE
1200
EMPLOYEES
$7.3B
IN REVENUE
27Copyright © Veeva Systems 2020
Microlearning
for GxP
28Copyright © Veeva Systems 2020
Benefits of Microlearning for GxP Training
“An organization's ability to learn and translate that learning into action is the ultimate
competitive advantage.”
- Jack Welch
Behavioral
Compliance
Targeted
Updates
Lower
Overhead
Just-in-time
Content
29Copyright © Veeva Systems 2020
Actionable Next Steps
How you can begin using micro-learning for GxP, tomorrow!
Use existing
resources
Start with high-risk
SOPs
Start small,
measure
everything
Succeed and
expand
30Copyright © Veeva Systems 2020
Additional Resources
Great microlearning titles by trusted voices Video series: GxP Training for life sciences
www.veeva.com/GxPTrainingVideos/
31Copyright © Veeva Systems 2020
John Constantine
john.constantine@orchestrallinc.com
Kent Malmros
kent.malmros@veeva.com
Questions?
How can we help.

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Micro-learning, Macro-compliance: Improving GxP Compliance with Modern Learning Techniques

  • 1.
  • 2. 2Copyright © Veeva Systems 2020 Disclaimer This presentation is for informational purposes only and does not constitute legal or other professional advice. You should consult your own legal or compliance team before making a compliance decision. All information is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied. In no event will Veeva be liable to you or anyone else as a result of your use on this information.
  • 3. 3Copyright © Veeva Systems 2020 John Constantine ORCHESTRALL John is a veteran of over 30 years in the life sciences industry, first at GlaxoSmithKline, then at Merck as Executive Director, Merck Polytechnic Institute in 2008, and joining Orchestrall, Inc. as Senior VP, Learning & Talent Solutions in 2016. His background includes Sales, Marketing, Corporate Staffs, Information Technology, Research and Development, and 25 years in Learning & Development. VEEVA SYSTEMS Kent has spent the majority of his career delivering technology-enabled training solutions to life sciences, holding leadership positions at industry leading companies such as AdMed, ClearPoint (Red Nucleus), UL EduNeering (UL), and now Veeva Systems. Kent Malmros
  • 5. 5Copyright © Veeva Systems 2020 GxP Training Then: Traditional Approaches Document-Centric Training on key policies and procedures as documented to standard templates, then authored, reviewed and approved in governed workflows. eLearning Libraries Content built around FDA guidelines specific to key GxP topics (Good Manufacturing Practices, etc.) that are key to remaining compliant. Macro-Learning Documents, eLearning or classroom training all based on multiple learning objectives built for instruction over large periods of time (one hour or more).
  • 6. 6Copyright © Veeva Systems 2020 GxP Training Now: Modernization Engagement Retain learner interest Storytelling opportunity Flexible approaches Device-friendly Competency Over completion Focused behavior Reinforcement Videos SOP replacement Work instructions Reference materials
  • 8. 8Copyright © Veeva Systems 2020 Microlearning is an instructional unit that provides a short engagement in an activity intentionally designed to elicit a specific outcome from the participant. - Microlearning: Short and Sweet. Karl Kapp and Roby DeFelice
  • 9. 9Copyright © Veeva Systems 2020 I can’t afford to make a lot of videos. Microlearning is not exclusively about video We don’t know how to change our approach. Don’t change, enhance your approach. Does your platform “have microlearning” Microlearning is not software Demystifying Microlearning What we hear everyday on the ground, makes it inaccessible to GxP trainers
  • 10. 10Copyright © Veeva Systems 2020 The Case for Microlearning As part of modernization It works. Science demonstrates that the framework is valid. Fits with modernizing concepts of Quality 4.0 and training Growing industry adoption and understanding
  • 11. 11Copyright © Veeva Systems 2020 We already use it Poll Question: What is your organization’s position on microlearning? We already use it, but not as part of GxP Training We don’t use it, but plan to in the next 12 months We don’t use it, and currently have no plans to
  • 12. 12Copyright © Veeva Systems 2020 Data Supporting Microlearning 12% 85% Sustained higher knowledgeIncrease in knowledge 2018 Microlearning Global Benchmark Report. Axonify
  • 13. 13Copyright © Veeva Systems 2020 What Microlearning is NOT Learning strategy considerations Curriculum design considerations NEW “Shrunken head” learning Right for every learning outcome About knowledge A complete learning ecosystem A resource library Wholesale replacement for other learning initiatives Microlearning: Short and Sweet by Robyn A. Defelice, Karl M. Kapp September 2019
  • 14. 14Copyright © Veeva Systems 2020 Defining Microlearning As part of modernization Microlearning Macro-Learning • I need help now • I want to learn something new • 2-15 minutes • Several hours or days • Declarative, conceptual knowledge • Problem solving, procedures, interpersonal skills • Search by asking a question • Content guided by others • Multiple modalities (video trending) • Multiple modalities (traditional eLearning or ILT) • Indexed and searchable • Coaching and support needed • Content rated for quality utility • Content consumed when delivered • Refresher learning • Deeper learning, building meaning • Videos, articles, code samples, job aids • Courses, classes, MOOCs, programs Microlearning: Short and Sweet by Robyn A. Defelice, Karl M. Kapp September 2019
  • 15. 15Copyright © Veeva Systems 2020 Common Microlearning Principles Size The most discussed attribute of microlearning is the shorter duration of learner seat time for training materials. Reinforcement Shorter materials mean easier opportunities for use beyond prescriptive assignments, which encourages re-use. Quizzing Less content can mean shorter, more targeted quizzes to ensure comprehension or competency on key topics. Video Microlearning is often thought to be a video-based modality; while it’s not, video is often a popular approach. Creation Fewer resources may be necessary to build a micro- learning asset, but more strategy is required. Delivery The type of microlearning you develop should take your delivery method into consideration.
  • 16. 16Copyright © Veeva Systems 2020 Defining Microlearning Five “Types” of Microlearning Primary PersuasivePost- Instruction Performance SupportPreparatory Microlearning: Short and Sweet by Robyn A. Defelice, Karl M. Kapp September 2019
  • 17. 17Copyright © Veeva Systems 2020 The Science Behind Microlearning Spacing of Key Content Avoiding Cognitive Overload Repetition and Reinforcement Zambito, Victor. (2018) The Brain Science of Microlearning: Why It Works. https://trainingindustry.com/articles/content-development/the-brain-science-of-microlearning-why-it-works/
  • 18. 18Copyright © Veeva Systems 2020 Data Supporting Microlearning 50% 50% More engagement Reduction in development costs Gutierrez, Karla (2018) Numbers Don’t Lie: Why Microlearning is Better for Your Learners (and You too) https://www.shiftelearning.com/blog/numbers-dont-lie-why-bite-sized-learning-is-better-for-your-learners-and-you-too
  • 19. 19Copyright © Veeva Systems 2020 Microlearning for GxP
  • 20. 20Copyright © Veeva Systems 2020 Making it engaging Poll Question: What are the biggest challenges you have with your GxP training program? Demonstrating competency Resource constraints Lack of executive support
  • 21. 21Copyright © Veeva Systems 2020 Growing Beyond GxP Training Shifting the emphasis beyond GxP and Quality True Digital Modified Objectives Media-centric Data Cleansing Microlearning drives the push away from “paper” Tailor learning objectives to meet smallest possible ”need” Consider any and every opportunity to replace documents with multimedia Opportunity to “weed” out old materials when re-factoring
  • 22. 22Copyright © Veeva Systems 2020 Microlearning as a Complement Focus RiskOperation R&D I MEDICAL I COMMERCIAL
  • 23. 23Copyright © Veeva Systems 2020 Examples of Applicable Microlearning SOP Replacement Why must SOPs be documents? Break up a procedure into smaller ones and then building corresponding learning assets Delta Training With existing dense documents, sending a revised SOP for training doesn’t convey changes; build a short slide or image to train Quick Reference Guides Summarizing a document in acceptable to augment GxP training; this can be done in any format that makes sense Video Work Instructions Developing shorter video-based work instructions encourages just-in-time use of learning assets as ongoing reference materials
  • 24. 24Copyright © Veeva Systems 2020 Specific Recommendations for GxP Microlearning SITE-BASED FLASH CARDS AR-BASED PERFORMANCE SUPPORT SPACED KNOWLEDGE CHECKS DIGITAL JOB AIDS SINGLE PROCEDURE VIDEOS
  • 25. 25Copyright © Veeva Systems 2020 Customer Use Case West coast emerging Biotech Shift away from traditional SOP training Revised learning strategy Variety of small assets to support learning objectives Desire for 21st century feel US, EU, ASIA STAFF HUGE CLINICAL TRIAL BASE 1200 EMPLOYEES $7.3B IN REVENUE
  • 26. 26Copyright © Veeva Systems 2020 Customer Use Case Outcomes App launched for company/personal devices to 210 clinical staff >5000 interactions in 6 months (all ”pull”) Uses: • Important management comms • Safety training (primary) • Follow up reinforcement • SOP chatbot pilot (AI-driven) US, EU, ASIA STAFF HUGE CLINICAL TRIAL BASE 1200 EMPLOYEES $7.3B IN REVENUE
  • 27. 27Copyright © Veeva Systems 2020 Microlearning for GxP
  • 28. 28Copyright © Veeva Systems 2020 Benefits of Microlearning for GxP Training “An organization's ability to learn and translate that learning into action is the ultimate competitive advantage.” - Jack Welch Behavioral Compliance Targeted Updates Lower Overhead Just-in-time Content
  • 29. 29Copyright © Veeva Systems 2020 Actionable Next Steps How you can begin using micro-learning for GxP, tomorrow! Use existing resources Start with high-risk SOPs Start small, measure everything Succeed and expand
  • 30. 30Copyright © Veeva Systems 2020 Additional Resources Great microlearning titles by trusted voices Video series: GxP Training for life sciences www.veeva.com/GxPTrainingVideos/
  • 31. 31Copyright © Veeva Systems 2020 John Constantine john.constantine@orchestrallinc.com Kent Malmros kent.malmros@veeva.com Questions? How can we help.