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Designing a Sustainable Training and Compliance Program. The Roadmap. 9:00 – 9:30 Breakfast and networking 9:30 – 11:00 Building and Implementing a quality and compliance learning programme - Elements of a sustainable & scalable programme - Role-based training formula

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Designing a Sustainable Training and Compliance Program


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agenda leaders in life sciences learning

9:00 – 9:30 Breakfast and networking

9:30 – 11:00 Building and Implementing a quality and compliance learning programme

- Elements of a sustainable & scalable programme

- Role-based training formula

- Optimisation through integrations

- Meeting goals: metrics, dashboards, reporting

- Best practices

11:15 – 11:30 Break

11:30 – 12:00 Company presentation/case study

12:00 – 12:30 Regulatory update

12:30 – 13:30 Lunch

13:30 – 15:30  User Group

15:30 – 16:00  Open discussion, concluding remarks and adjournment

Agenda: Leaders in Life Sciences Learning
the road to compliance and training success
The Road to Compliance and Training Success
  • Do you feel that you have a plan?
  • Does it have many spokes or is the road straight and clearly defined?
  • How do you measure success?
the road starts with
The road starts with …

striving for compliance. But, the road does not end there…

Knowledge Solutions that Assure Compliance and Improve Business Performance

How can you and your company develop the long-term plan to Improve Business Performance?

business challenges
Business Challenges
  • Performance issues impact product quality
  • Difficulty with new hire induction
  • Unable to easily track training history by employee
  • Unqualified personnel operating complex equipment
  • Managing External Training
  • “Stigma” of compliance training
  • Global Training Challenges
  • Too much paper – heavy administrative burden
  • Unable to keep up with ever-changing regulatory requirements
  • Lack of conformance to Internal Policies/Procedures
  • How to validate delivery & understanding of critical Information
  • How to make training engaging
key considerations for success
Key considerations for success
  • What is driving the programme? Corporate initiative or regulatory action?
  • Have the executive sponsors support the initiative?
  • Do you understand your users and corporate culture?
  • Have you assessed your organisational structure and role-based training requirements
  • How quickly to adopt new programme elements?
    • Speed of change, appetite for change
  • How to measure, report and manage progress and risk
  • What is your strategy for keeping the programme valid and applicable
you ve got to have a plan
You’ve got to have a plan …

or you’ll get lost

  • Know your objective
  • Plan your route
  • Assess the risks
  • Avoid traffic chaos
  • Don’t get distracted
  • Good documentation
  • Technology helps
aligning with organisational objectives
Aligning with Organisational Objectives
  • Pro-active approach
  • Agreed & Documented
    • High level guiding principles
    • Working level procedures
  • Objectives
  • Training standards
  • Consistency throughout
  • Timely maintained
prioritise training
Prioritise Training
  • Based on need
  • Analyse the risk to the organisation
  • Identify critical factors
    • People
    • Tasks
  • Quantify impact
  • Timely delivery
  • Invest more in highest priorities
lessons from toyota
Lessons from Toyota
  • Failure to identify root cause
  • Failure to recognise trends in "adverse events"
  • Failure to employ policies and procedures to enable rapid ow of critical information across the organisation
  • Failure to adapt to working, learning + cultural conditions of global enterprise
  • Failure to provide regulators with full and accurate safety records and complaint history
  • Failure to manage quality of supplier products
  • Failure to recognise the impact of rapid growth on corporate culture
appropriate training materials instructors

Instructors

Use SMEs

Knowledgable

Skilled Communicators

Qualified & Current

Appropriate Training, Materials & Instructors
  • Training
    • Analyse task / skill
    • Break down into discrete steps
    • Train each step
    • Blend different methods. (OJT, Classroom, Online)

Training must be effective

appropriate metrics, feedback, surveys

  • Materials
    • Well Developed
    • Native Language
    • Interesting & Varied
training function is the hub
Training Function is the Hub

Training Drivers

Cultural, Strategic, Legislative, Personal

  • Customer Groups
    • Individual, Organisational
  • End User

Your organizations customers benefit from improved product quality, and efficacy

monitor adjust change
Monitor, Adjust & Change
  • Effectiveness should be monitored
  • Regulatory advice – track operator errors
  • Modify materials as needed
  • Feedback from trainees
  • Trained personnel should demonstrate improved performance
  • Change training in good time
documentation
Documentation
  • All aspects of training to be documented
  • Version & Change Control
  • Meet needs of Org & External Audit

Efficient & Cost Effective

  • Minimize waste
  • Measure ROI
  • Demonstrate Value to Organisation
working together
Working Together
  • Management Stakeholders
    • Set clear expectations
    • Support appropriate training methods (OJT, Classroom, On-line)
  • Trainers
    • Resources, time, investment
    • Development of training materials
  • Trainees (learners)
    • Required to perform task post training
    • Require efficient use of their time
    • Require effective training
    • Provide dedication and commitment

These groups must work towards a common goal

senior management support
Senior Management Support
  • Critical Success Factor
  • Management Provide
    • Resources
    • Time
    • Personnel
    • Funding
  • Training is an investment in the future
slide21

Deliver …

RightTraining to

Right Users @

Right Time

the roles based training formula

Company Level

HR, Legal, Corporate

Location Level

Facility-Specific (EH&S)

DeptLevel

SOP, Departmental P&P

RoleLevel

SOP, Job-Specific

The ROLES Based Training Formula

R eview your training matrix

O rganize training into Curricula

L everage User Groups

E mploy Recurring Assignments

S ystem Maintenance

r oles r eview your training matrix
ROLES: Review Your Training Matrix
  • Review what you have now (be honest)
  • Determine what is missing
  • Perform a risk based analysis
  • Start slow and build with consistency
  • Build your internal processes
r o les o rganize training into curricula
ROLES: Organize Training into Curricula
  • Manageable Size
  • Curriculum Types
  • Due Dates / Retraining Periods
  • Sequencing
  • Define your process for maintaining curricula
ro l es l everage user groups
ROLES: Leverage User Groups
  • User Groups are “Containers” for users
  • Use Custom Field values as automated membership criteria
  • Use Suggested Membership for cross-training and developmental assignments
  • Use Group Types for cataloging of User Groups and for creating hierarchical arrangements of your Groups
rol e s e mploy recurring assignments

Role-Based User Groups

Role-Based Curricula

Location Level

Company Level

DeptLevel

RoleLevel

ROLES: Employ Recurring Assignments

Recurring Assignment

role s s ystem maintenance
ROLES : System Maintenance
  • Standardize nomenclature and other meta data
  • Create an assign Security Roles as appropriate
  • Decentralize system administration where and how it is appropriate
  • Monitor the system through standardized reporting
  • Maintain control of data entry and system usage through documented procedures and monitoring
    • Users, Training Items, Curricula, User Groups
  • This is an exercise in continuous improvement
  • There may be on-going consolidation and refinement opportunities
refining your training program continuous improvement
Refining Your Training Program – Continuous Improvement
  • Audit and Maintain your System
    • Process, Process, Process!!!
    • Garbage In = Garbage Out!
  • Periodic Needs Analysis
    • Maintain the Accuracy of your Training Matrix
  • Keep your Training Materials Fresh
  • Expand your Program to Other High Risk Areas
    • Clinical Trials
    • Supply Chain
    • Other Plants, Locations, Divisions, Business Units, etc.
optimization driving forces
Optimization Driving Forces

Baseline Value

Value Add

Administration Reduction

Automate Data-Entry through Interoperability with Internal Systems

Increase sustainability & longevity

Reduce Compliance Risk

Develop long-term relationships with training recipients

Increase customer satisfaction

  • Administrative Volume
  • Quantify your level of effort
  • Identify gaps with manual processes
  • Compliance Risk
  • Level of Visibility
  • Turn-around Time
  • Overhead Cost
  • Price
tools for optimization
Tools for Optimization

Best Practice

  • HRIS - Synchronizing user profile information
  • EDMS - Synchronizing training content
  • MES - Compliance Status Verification
slide33

IMPROVEMENTS

  • Documented objective training requirements
  • Documented objective non-ambiguous evidence of training / qualification
  • Consistent implementation of training requirements across roles
  • Proactive, not Reactive
  • Global Visibility
  • EFFICIENCIES GAINED
  • Reduced risk of non-compliance
  • Reduced Administration
  • Reduction in Human Error
  • Data Integrity

Sophistication

Inefficiency

Sophistication of Implementation &

Scope of Business Needs

slide34

Professional Development Program

Your Development Journey

My Development Progress

My Development Planning

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Description of this section here

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metrics reporting
Metrics & Reporting:

Communicating to Executive Management

executive management communications
Executive Management: Communications
  • Metrics / Reporting must be:
    • Clear – Presented in a manner that is self explanatory
    • Concise – Summary level information with detail as a backup
    • Reliable – Information must be generated in a consistent fashion
    • Timely – so that trend changes are quickly identified
    • Actionable – Management must be able to make business decisions based upon this information!
management dashboards clear
Management Dashboards: Clear
  • This dashboard view lets management know that their company wide compliance status is currently 100%.
  • It also provides them with a minimum and optimum compliance ranges
  • It lets them know the total number of users who are in compliance, at risk, and/or not in compliance with regard to their assigned training
management reporting clear
Management Reporting: Clear
  • With this User Qualification Summary Report, management is able to quickly understand the level of compliance within their organization.
  • In this example, individuals within the quality department who are at risk and / or who are currently out of compliance are designated by the colors red and yellow.
  • Fully qualified individuals are designated by the color green
management dashboards concise
Management Dashboards: Concise
  • Management also needs the ability to access summary level information such that users who are at risk or out of compliance can be quickly identified
  • Detailed level information can be accessed by clicking on each user column under the heading of “In Compliance”, “At Risk” or “Out of Compliance”
management reporting concise
Management Reporting: Concise
  • Management also needs the ability to access summary level information in report form.
  • The ability to create report queries that can be rerun on demand fulfills the need for this type of management reporting
  • Additionally, these reports can either be printed and or downloaded into an excel file for further analysis
  • This particular saved completions report will generate one year’s worth of training and equivalent completions for all enabled users
management dashboards timely
Management Dashboards: Timely
  • This dashboard view allows management to quickly view historical compliance status information so that negative trends can be quickly identified and reversed.
management dashboards reliable
Management Dashboards: Reliable

The KE Learning Management System (LMS) is validated and must therefore produce information that is:

  • Dependable: Worthy of reliance of trust
  • Authentic: Conforming to a fact or set of facts
  • Consistent: Capable of being reproduced
  • Reproducible: Capable of creating a copy or producing an equivalent
management dashboards actionable
Management Dashboards: Actionable
  • Management is able to quickly make decisions based upon the information presented in the dashboard because it is clear, concise, timely, reliable, and most importantly…ACTIONABLE!
metrics pulling it all together
Metrics: Pulling It All Together

Measure your compliance goals

Printable format

View Trending

Data

Drill Down to View Users

Drill Down to Lower Org levels