Training That Transforms: A Quality Approach
Training That Transforms: A Quality Approach
• Define Regulatory
requirements Gap
• Compare requirements Assessment
to current systems
• Identify Action Items
• Build plan based on Action
Items
Compliance • Implement Quality Systems
Program • SOP Writing
• Training Services
• Prepare for audit Inspection
• Support during audit
Support
• Defense support after
audit
QA
• Audit Services*
Associate • Maintain Quality System
• Vendor Management
• Continuous Improvement
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Our experienced MMS colleagues can support your training needs
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The Importance of Training
What is Training
Learning is the acquisition of skills and knowledge through training, education and
experience.
Training seeks to impart a set of skills with a specific outcome, without the necessity
of the trainee to understand why they need to act in a specific way.
RQA 2015 publication Management of the training and competency of personnel in GxP and research environments
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Learning Versus Training
Learning Training
• Engaging the individual to build skills and • A structured experience usually correlating to
knowledge specific areas of an individual's role
• Ongoing process for employers and • Teach the individual how to perform specific
employees tasks e.g. Induction sessions for new staff,
regulatory training
• Long term process of taking in information
and retaining it e.g. on the job training
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www.aihr.com
The Importance of Training
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Effective Trainers: Presenting the Training
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Effective Trainers – Planning the Training
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Effective Trainers: Evaluating the Training
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Enhancing Trainee Engagement
Learning Styles: Knowles’ Adult Learning
Identified 5 characteristics for adult learners:
Learn and
Self-directing devote energy
on a daily issue
Increased
Why should Wealth of Self-esteem as
I Learn this? Experience a motivation
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Learning Styles: Kolb versus Honey and Mumford
Convergers
Pragmatist
Feeling and
Doing and
Divergers
Reflector
Watching
Convergers / Pragmatist
Thinking
Diverger / Reflector:
Practical application of Concrete experience,
theoretical information Reflective observation
Assimilators
Watching and
thinking
Assimilator/ Theorist
Reflective observation,
Abstract conceptualization
Theorist
Kolb, D. A. (1984). Experiential Learning: Experience as the Source of Learning and Development. Englewood Cliffs, NJ: Prentice Hal 18
“
I hear and I forget.
I see and I remember.
I do and I understand.“
-
Confucius
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Training Lifecycle Technique
What are the stages in the Training Life Cycle?
1
Identify the
training
needs
Evaluate Develop
5 the Learning 2
Training Objectives
Deliver Design
the the 3
Training Training
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1. Identify Training Need
A training needs analysis can assess the specific training that is
required (the gap) versus the current skill and knowledge levels
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3. Design the Training
• Choose the best format for the training and include activities
• Create a plan for the training-map introductions, ice breakers
and activities
• Know your time limit. Prepare slides with enough time for
questions
• Organize the information with a logical flow to absorb the
audience
o Choose your title appropriately
o Have a clear but short Introduction and use an Ice
Breaker
o Segment the training into appropriate sections including
breaks and summarize at each section end
o Ensure the body of the presentation is clear and concise
o Conclusion: reiterate main points for the take home
messages
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4. Deliver the Training
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5. Evaluate the Training: Kirkpatrick’s
Four Levels
Level 1 • Measures trainee feedback immediately after training
Reaction • Surveys, Questionnaires
Environment Format IT
Props Timings
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Interactive Training Tools and Visual Aids
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Training Activities: Considerations
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Any questions?
Thank you
About MMS
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries
with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong
industry experience and a data-driven approach to drug development make MMS a valuable CRO partner,
creating compelling submissions that meet rigorous regulatory standards. With a global footprint across
four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best
Global Biotech CRO in the 2018 International Life Sciences Awards.
For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.