Designing a Sustainable Training and Compliance Program

The Roadmap

Agenda: Leaders in Life Sciences LearningLeaders 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

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?

striving for compliance.

But, the road does not end there…

The road starts with …

Knowledge Solutions that Assure Compliance and Improve Business Performance

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

• 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

Business 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

• 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 …

• Know your objective

• Plan your route

• Assess the risks

• Avoid traffic chaos

• Don’t get distracted

• Good documentation

• Technology helps

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

• 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

• 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

Training Complexity

Kind of Training Awareness

Structured & Tested Qualification

SME Qualification

Characteristics No Assessment Training + KTA Training + SDA Qualification across relevant SOPs

Level Low High

KTA: Knowledge Transfer AssessmentSDA: Skill Demonstration Assessment

Consider different learning styles

Appropriate Training, Materials & Instructors

• Instructors- Use SMEs

- Knowledgable

- Skilled Communicators

- Qualified & Current

• Materials- Well Developed

- Native Language

- Interesting & Varied

• Training- Analyse task / skill

- Break down into discrete steps

- Train each step

- Blend different methods. (OJT, Classroom, Online)

Training must be effectiveappropriate metrics, feedback, surveys

Training Function is THE Hub

Training Drivers Cultural, Strategic, Legislative, Personal

Customer Groups

Individual, Organisational

End UserYour organizations customers benefit from improved product quality, and efficacy

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

• 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

• 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

• Critical Success Factor• Management Provide

- Resources

- Time

- Personnel

- Funding

• Training is an investment in the future

Developing Your Learning Culture

Visibility to Learning in an Organization

The ROLESROLES Based Training Formula

Company Level

Company Level

Location Level

Location Level

DeptLevelDeptLevel

RoleLevelRoleLevel

HR, Legal, Corporate

Facility-Specific (EH&S)

SOP, Departmental P&P

SOP, Job-Specific

R R eview your training matrix

O O rganize training into Curricula

L L everage User Groups

E E mploy Recurring Assignments

S S ystem Maintenance

RROLESOLES: 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

RROOLESLES: : OOrganize Training into Curricula

• Manageable Size• Curriculum Types• Due Dates / Retraining Periods• Sequencing• Define your process for maintaining curricula

ROROLLESES: 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

ROLROLEESS: Employ Recurring Assignments

Recurring Assignment

Role-Based User Groups Role-Based Curricula

Company Level

Location Level

DeptLevel

RoleLevel

ROLEROLESS : 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

ROLESROLES: Training Metrics

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.

Optimizing Your Training System

Optimization Driving Forces

Baseline Value

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

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

Tools for Optimization

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

EFFICIENCIES GAINED

Reduced risk of non-compliance

Reduced Administration

Reduction in Human Error

Data Integrity

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

Sophistication of Implementation &Scope of Business Needs

So

ph

isti

cati

on In

efficiency

Professional Development Program

Your Development JourneyMy Development Progress

My Development

Planning

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Metrics & Reporting:

Communicating to Executive Management

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

• 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

• 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 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 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

• 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

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 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

View TrendingData

Drill Down to Lower Org

levels

Measure your compliance

goals

Drill Down to View Users

Printable format