Enhance Learning Efficiency in LIfe Sciences with Industry-Leading Learning Content & Technology

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Copyright © Veeva Systems 2021
Presenters
Kent Malmros
Senior Director
Vault Training
Graham O’Keeffe
General Manager,
LearnGxP

Presentation Title Goes Here
Enhance Learning Efficiency
with End-to-End Life Science Training Solution

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• How adding a standard GxP content library to your LMS increases
training efficiency
• The best place to start with eLearning content
• Scaling your use of a GxP training library based on organizational
maturity
• Partnering with Veeva for your ongoing learning strategy needs
Objectives

How adding a standard GxP
content library to your LMS
Increases training efficiency

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1. Completed documents (SOPs) that outline task-level behavior
2. Content that explains the governing regulations & standards
3. Records managed in a GxP LMS
Content • Technology • Data
The Parts of Qualification
When an FDA Inspector asks if you have qualified your
learners, they expect three things

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Pharmaceutical
21 CFR Part 211.25
Current Industry Trends
(a)“Training in current good manufacturing
practice shall be conducted by qualified
individuals on a continuing basis and with
sufficient frequency to assure that employees
remain familiar with CGMP requirements
applicable to them.”
Source: TheFDAGroup.com

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Medical Device
21 CFR Part 820.25
Current Industry Trends
(a)“Each manufacturer shall have sufficient
personnel with the necessary education,
background, training, and experience to
assure that all activities required by this part
are correctly performed.”

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The Frequency is Increasing
“Six regulations saw a significant increase in the frequency with which they were
cited between 2018 and 2019”
Source: TheFDAGroup.com

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What’s Expected of a Training Professional?
Ensure training data
is current and
accurate
Generate, review and
distribute training
reports for managers
Responsible for
administration and
management of GxP
Training Program
Prepare, distribute,
collect and evaluate
training assessments
Perform scheduling
of training rooms
Maintain employee
training files
Ensure that SOP
training is rolled out to
appropriate personnel
Responsible for
managing delivery of
instructor-led training

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Life Cycle Stage Responsible Person No of Days Cost ($1,250 per day)
1 Script Creation SME 1 10 $12,500
2 Script Review Cycles SME 2 5 $6,250
3 Final Approval SME 1&2 1 $1,250
4 Voice Over Production Voice Over Artist 3 $3,750
5 Voice Over Review Quality 1 $1,250
6 Wireframing of Online Course ID & SME & Quality 5 $6,250
7 Course Creation ID’s 15 $18,750
8 Course Review Cycles & Edits ID & Quality 10 $12,500
9 Final Approval ID & Quality 1 $1,250
10 Accreditation Documentation Quality 2 $2,500
11 Transfer SCORM to LMS IT 1 $1,250
12 Publish and Final Quality Check Quality 1 $1,250
Total 55 Days $68,750
Why it’s so difficult to create training?
Access over $12 million of GxP training for less than the cost of one course!

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Bringing Training Types Together
Training Plan
Comprehensive Materials
Job-Based Behaviors
Governing Regulations
Defensible Training Approach
Qualification
SOPs
Policies
Work Instructions
Regulations
Classroom Training
Video
eLearning

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When eLearning Delivers Efficiency
When you need to train on >3 regulations
Classroom training co-mingles qualification
and regulation training
Your training plan is on the verge of scaling
across the broader organization

The Best Place to Start
with eLearning Content

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1. Consider your content development resources
2. Ensure you understand the capabilities of your LMS
3. Err on the side of inspection-readiness
Develop a Repeatable Learning Strategy
It doesn’t have to be complex, but it has to provide a
framework to allow consistent decisions

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THE STRATEGIC
BLUEPRINT
DEVELOP &
REVIEW
SHORT VS.
LONG
IDENTIFY
SMEs
IDENTIFY
NEEDS
REVIEW
OUTCOMES

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What are you qualification sets?
STEP 1: IDENTIFY NEEDS
What information is available for training
currently? Documents? Videos?
If something already exists, is it working?
Do new tactics need to be tried?
IDENTIFY
NEEDS

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Who are the key SMEs for a given topic? Are
they internal or external?
STEP 2: IDENTIFY SME(S)
 Can they create content?
 Can they review content on an
ongoing basis?
IDENTIFY
SMES
Have they ever written training materials
before? Do they have instructional design
support?

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Does the learning objective require
microlearning to be impactful?
STEP 3: SHORT VS.
LONG
What, then, is the right format?
Would microlearning deliver to an engaging
singular objective?
How does the desired modality fit your
available delivery mechanisms?
SHORT VS.
LONG

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CONTENT
STEP 4: DEVELOP & REVIEW
Leverage available resources (or find
resources in Step 6) to develop training
assets to meet objectives
Ensure QA/QC process
Have a plan to manage the complementary
asset development process
Engage SMEs in review process, alongside
the IDs and developers

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Ensure that measurement is part of the overall plan
and review outcomes at all steps
STEP 5: REVIEW
OUTCOMES
Pilot data can allow for early changes
Steady-state data should be consistently
reviewed
MEASUREMENT
Develop different measurement
frameworks for different objectives
Develop different measurement
frameworks for different training types

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A Strategic Blueprint provides:
FINAL TAKEAWAYS
 The big picture view for planning programs
and curricula that meet business and
learning needs
 A framework for evaluating programs that
currently exist
 A tool for prioritizing investments in
learning
 A method to get the most out of the
training tools available
DEVELOP &
REVIEW
SHORT VS.
LONG
IDENTIFY
SMEs
IDENTIFY
NEEDS
REVIEW
OUTCOMES

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Start Your eLearning Efforts
If you have an internal instructional design
or multimedia developer
Your LMS is SCORM compatible, and you
have a need for a minimum 3x3 matrix
You have a limitation on SMEs for all
organizationally critical regulations

Scaling Your Use of a
GxP Training Library
Based on Organiztional Maturity

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1. Observe recent quality events as a starting point
2. Align regulatory content to functional areas
3. Start with 101 or prescribed learning paths
4. Give usage decision to curriculum owners
Build eLearning Use Like Document Training
License an eLearning library that can meet extensive needs,
then add incrementally to department level curricula

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Developing Training is Complicated
Finding someone
when you want
them
Outside Vendors Internally Software Tools People
Finding someone
within your
budget
Finding someone
with the right
experience
Finding SME’s
that have time to
help
Finding the
budget to create
the training
Trying to manage
with other job
functions
Instructional Designers
Voice Over Artists
Project Managers

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SOP-MANU-006, 007,
008, 121, 154
ELM-710: Effect of Not
Following cGMP
Learner Roles
Curricula
ELM-722: Intro to cGMP
ELM-105-04:
Microlearning
ELM-105-05:
Microlearning
Final Exam
Accredited online courses
Standard Operating
Procedure
Microlearning Videos
Final Exam
cGMP - Beginner cGMP – Intermediate
SOP-MANU-120, 134,
123, 187, 145
ELM-209: 21 CFR
Subpart G
ELM-212: 21 CFR
Subpart D
ELM-212-01:
Microlearning
ELM-209-01:
Microlearning
Final Exam
SOP-MANU-006, 008,
007, 0134, 1987
ELM-705: Microbial
Contamination
ELM-401: Process
Validation
ELM-401-01:
Microlearning
ELM-705-01:
Microlearning
Final Exam
cGMP – Refresher
The Power of One Solution

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A modern fresh
approach to GxP
training
www.learngxp.com

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Demo

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One solution – Our content
The following are key reasons why Veeva Learnaboutgmp can ensure
your personnel are trained adequately to perform their assigned responsibilities.
170+
Accredited Courses
500+
Micro Learning Videos
30+
Learning Paths
10+
New Assets
The only accredited online
GxP training available globally
to ensure continuous
compliance
Engage learners better with
specific targeted training of
shorter duration for
reinforcement
Learning Paths are a selection
of courses tied together for
learners to progress through,
mastering a particular subject
New training assets added
every month to help training
leaders deliver content that is
engaging, impactful and
meaningful
View Catalog View Catalog View Catalog

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Scaling Use of an eLearning Library
Harmonize training so everyone on the
same page
Your curricula keep evolving with your
organization
Don’t overwhelm your training resources

Partnering with Veeva
For your Long-Term Learning Strategy Needs

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One Powerful Solution
Customer
Success
MODERNIZED APPPOACH
TO GxP TRAINING
ENSURE TRAINING
COMPLIANCE
CONTINUALLY UPSKILL
WORKFORCE
AVOID TRAINING
RELATED CITATIONS

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1. GxP-focused LMS and eLearning give organizations the right
foundation for training
2. Ongoing strategic consulting to build your plan
3. Continually evolving features and titles
How Veeva Can Help You
Content and technology that are industry-focused deliver on
the opportunity to create ultimate efficiency

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Training Strategy – Steps 1 to 5
LearnGxP + Vault Training
Identify Needs
Step 1
Identify SMEs
Step 2
Business Alignment
Step 3
Short Vs Long
Step 4
Strengths & Gaps
Step 5

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Training Strategy – Steps 6 to 10
LearnGxP + Vault Training
Development Team
Step 6
Develop & Review
Step 7
Conduct Pilot
Step 8
Review Outcomes
Step 9
Finalize Curricula
Step 10

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One solution – Our process
We’ve developed a six-step process to ensure ongoing customer success
Strategy
• Assess capability
gaps
• Align with business
strategy
• Short Vs long term
goals
• Develop marketing
strategy
• Roll-out strategy
• Performance
measurement (ROI)
Training
“We have gone through
the rigorous application
process for IACET
accreditation, to
demonstrate our
organization’s
commitment to
continuing education
and training excellence.
We ensure our students,
customers and other
participants get the best
return on their
investment.”
Microlearning
• Increase knowledge
retention
• Deploy to critical
business areas
• Create higher impact
• Less time consuming
• Accessible to
everyone
• Supplement to formal
training
Customization
• Tailored to your
business
• Aligned with your
procedures
• Harmonize globally
• Online collaboration
with SME’s
• Easy content
revisions
• Eliminate expensive
in-house course
development
Translation
Step 1 Step 2 Step 3 Step 4 Step 5
“Our translation service
localizes custom or
existing courses into a
target language, so that
your entire workforce
can effectively
participate in critical
training, regardless of
their location and native
language.”
Marketing
Step 6
• Promotion of training
• Custom branded
newsletters
• Custom landing pages
• Online banners and
adverts
• Scheduled campaigns
• Flexible with business

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•“I’ve been in quality & operations for 20+
years and this is the first solution to ever
offer all this training in one easy to use
place for companies to access. You are
truly providing an amazing service!”
• Global Director Learning & Development

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Partnering with Veeva
Learning content, learning technology
or both
Industry practitioners that can relay best
practices to ensure success
Continuous innovation driven by
customer input

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