Designing a Sustainable Training and Compliance Program

1. Designing a Sustainable Training and Compliance Program The Roadmap

2. 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

3. 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?

4. 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?

5. 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

6. 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

7. 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

8. Aligning with Organisational Objectives • Pro-active approach • Agreed & Documented • High level guiding principles • Working level procedures • Objectives • Training standards • Consistency throughout • Timely maintained

9. 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

10. 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

11. Training Complexity

12. Consider different learning styles

13. 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

14. 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

15. 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

16. 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

17. 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

18. Senior Management Support • Critical Success Factor • Management Provide • Resources • Time • Personnel • Funding • Training is an investment in the future

19. Developing Your Learning Culture

20. Visibility to Learning in an Organization

21. Deliver … RightTraining to Right Users @ Right Time

22. 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

23. 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

24. ROLES: Organize Training into Curricula • Manageable Size • Curriculum Types • Due Dates / Retraining Periods • Sequencing • Define your process for maintaining curricula

25. 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

26. Role-Based User Groups Role-Based Curricula Location Level Company Level DeptLevel RoleLevel ROLES: Employ Recurring Assignments Recurring Assignment

27. 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

28. ROLES: Training Metrics

29. 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.

30. Optimizing Your Training System

31. 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

32. Tools for Optimization Best Practice • HRIS - Synchronizing user profile information • EDMS - Synchronizing training content • MES - Compliance Status Verification

33. 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

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35. Metrics & Reporting: Communicating to Executive Management

36. 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!

37. 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

38. 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

39. 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”

40. 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

41. 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.

42. 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

43. 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!

44. 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