Leverage Learning Technologies to Meet Your Compliance Regulations

1. Sponsored by: Leverage Learning Technologies to Meet Your Compliance Regulations Facilitator: Bryan Chapman Chief Learning Strategist Chapman Alliance bryan@chapmanalliance.com EPA FDA SOX SEC OSHA

2. I’m not going to talk about… History of compliance and regulatory requirements Recent fines and penalties (you can easily look these up) The benefits of adhering to compliance standards …or any other background information Rather, let’s jump into some actionable steps and recommendations for leveraging learning technologies!

3. Which regulatory requirement documents have you actually read? (check all that apply) Where are you in the process? • 21 CFR, Part 11 • HIPAA • OSHA (29 CFR) • ISO 9000 • Sarbanes-Oxley (SOX) • Other (which ones) • None of these Polling Question

4. CFR, Part 11

5. CFR, Part 11 regulation • Validation (consistent process, repeatable) • Accurate Reporting • Archival Protection of Records • Computer-Generated, Time-Stamped Audit Trail • Controls over Documentation (well established process over document distribution and sign off) • Electronic Signature System to determine that persons have “education, training, and experience to perform their assigned tasks”

6. Signatures can either be… Hand Written Biometric Digital Signature

7. Learning Management System LMS Off-the-shelf, pre-built courses Virtual Classroom Synchronous Learning • Instructor-led, Real time, Online • Connecting geographical disperse learners • Groups of learners meet together • Ready-to-use content (courseware) • Easy to find: IT skills, leadership, safety • Hard to find: very specific, job-related skills Authoring Tools Self-Paced, Self-Service Online Learning • 24 X 7 X 365 access to courses • Completed at learner’s own pace • Remediation and feedback are automated • Developed once, used many times • Automated scoring and completion status • Custom development • Screen design and layout • Interactive exercises • Tests, Quiz, Assessment • Simulations • Central Access to Learning • Individualized Learning Plans • Reporting & Completion Tracking • Instructor-Led Training Scheduling • Launch and track online learning • Certification Management • Competency Management • Skill Gap Analysis • Archiving records • Automating Digital Signatures Learning Content Management Informal Learning, Knowledge On Demand • Manage large-scale development (workflow) • Reusable learning content • Searchable repository of source material • Just-in-time, anywhere, anytime • Capture and retain organizational knowledge • Facilitates collaboration

8. Learning Management System LMS Off-the-shelf, pre-built courses Virtual Classroom Synchronous Learning • Instructor-led, Real time, Online • Connecting geographical disperse learners • Groups of learners meet together • Ready-to-use content (courseware) • Easy to find: IT skills, leadership, safety • Hard to find: very specific, job-related skills Authoring Tools Self-Paced, Self-Service Online Learning • 24 X 7 X 365 access to courses • Completed at learner’s own pace • Remediation and feedback are automated • Developed once, used many times • Automated scoring and completion status • Custom development • Screen design and layout • Interactive exercises • Tests, Quiz, Assessment • Simulations • Central Access to Learning • Individualized Learning Plans • Reporting & Completion Tracking • Instructor-Led Training Scheduling • Launch and track online learning • Certification Management • Competency Management • Skill Gap Analysis • Archiving records • Automating Digital Signatures Learning Content Management Informal Learning, Knowledge On Demand • Manage large-scale development (workflow) • Reusable learning content • Searchable repository of source material • Just-in-time, anywhere, anytime • Capture and retain organizational knowledge • Facilitates collaboration

9. Learning Management System LMS Off-the-shelf, pre-built courses Virtual Classroom Synchronous Learning • Instructor-led, Real time, Online • Connecting geographical disperse learners • Groups of learners meet together • Ready-to-use content (courseware) • Easy to find: IT skills, leadership, safety • Hard to find: very specific, job-related skills Authoring Tools Self-Paced, Self-Service Online Learning • 24 X 7 X 365 access to courses • Completed at learner’s own pace • Remediation and feedback are automated • Developed once, used many times • Automated scoring and completion status • Custom development • Screen design and layout • Interactive exercises • Tests, Quiz, Assessment • Simulations • Central Access to Learning • Individualized Learning Plans • Reporting & Completion Tracking • Instructor-Led Training Scheduling • Launch and track online learning • Certification Management • Competency Management • Skill Gap Analysis • Archiving records • Automating Digital Signatures Learning Content Management Informal Learning, Knowledge On Demand • Manage large-scale development (workflow) • Reusable learning content • Searchable repository of source material • Just-in-time, anywhere, anytime • Capture and retain organizational knowledge • Facilitates collaboration

10. Where are you in the process? Learning Management System LMS Which components of a learning infrastructure do you already have in place? Off-the-shelf, pre-built courses Virtual Classroom Synchronous Learning Authoring Tools Self-Paced, Self-Service Online Learning Informal Learning, Knowledge On Demand Learning Content Management Polling Question

11. Components

12. CFR, Part 11 favors electronic vs. paper delivery Advantages listed right in the document: • Advanced Search of Information (eliminating search of manual records) • Permitting information to be viewed from multiple perspectives • Identifying trends, patterns and behaviors • Avoiding document misfiling that may result from human error

13. Assessing Competencies

14. Gap Analysis  40 Technical Skills 

15. Gap Analysis

16. Gap Analysis

17. HR Training Is your organization currently doing gap analysis? Where are you in the process? • Yes. In both Training and HR • Yes. In HR only • Yes. In Training only • No, or not much Polling Question

18. Gap Analysis Approach

19. Learning Management System LMS Does the word “competency” mean the same thing to both groups? New Company Human Resources Training Radiology Technician: • Follows correct procedure to calibrate X-ray equipment • Practices seven steps to mixing chemicals without endangering patients • When encountering a difficult patient, practices proper engagement strategy Radiology Technician: • Operates X-ray equipment • Good people/patient skills • Practice patient safety • Teamwork/Collaboration

20. Regulatory Compliance – Maturity Model Good Better Best

21. Where are you in the process? What level are you at in the regulatory-compliance maturity model? Polling Question

22. Regulatory Maturity

23. Blended Learning Safety information HIPAA on-the-job “culminating experience” Self Assessment Lab Simulations GXP Word .PDF Practice Role Play Simulations PowerPoint Standard Operating Procedures

24. Blended Learning Safety information HIPAA on-the-job “culminating experience” Self Assessment Lab Simulations GXP Word .PDF Practice Role Play Simulations PowerPoint Standard Operating Procedures

25. Bloom’s Taxonomy • Knowledge • Action verbs: list, define, tell, describe, identify, show, label, collect, examine, tabulate, quote, name, who, when, where, etc. • Comprehension • Action verbs: summarize, describe, interpret, contrast, predict, associate, distinguish, estimate, differentiate, discuss, extend, etc. • Application • Action verbs: apply, demonstrate, calculate, complete, illustrate, show, solve, examine, modify, relate, change, classify, experiment, discover, etc. • Analysis • Action verbs: analyze, separate, order, explain, connect, classify, arrange, divide, compare, select, explain, infer, etc. • Synthesis • Action verbs: combine, integrate, modify, rearrange, substitute, plan, create, design, invent, what if?, compose, formulate, prepare, generalize, rewrite, etc. • Evaluation • Action verbs: assess, decide, rank, grade, test, measure, recommend, convince, select, judge, explain, discriminate, support, conclude, compare, summarize, etc.

26. Pilot Training

27. Regulatory requirement = blended learning …determine that persons have “education, training, and experience to perform their assigned tasks” “The agency regards this requirement as fundamental to the proper operation of a facility. Personnel entrusted with important functions must have sufficient training to do their jobs… General industry experience would not necessarily prepare someone to begin specific, highly technical tasks at a given firm. Some degree of on-the-job training would be customary and expected. The agency believes that documentation of such training is also customary and not unreasonable.”

28. Regulatory requirement = blended learning …determine that persons have “education, training, and experience to perform their assigned tasks” How do we define “sufficient”? “The agency regards this requirement as fundamental to the proper operation of a facility. Personnel entrusted with important functions must have sufficient training to do their jobs… General industry experience would not necessarily prepare someone to begin specific, highly technical tasks at a given firm. Some degree of on-the-job training would be customary and expected. The agency believes that documentation of such training is also customary and not unreasonable.”

29. Reactive vs. Proactive compliance

30. Learning Management System LMS Off-the-shelf, pre-built courses Virtual Classroom Synchronous Learning • Instructor-led, Real time, Online • Connecting geographical disperse learners • Groups of learners meet together • Ready-to-use content (courseware) • Easy to find: IT skills, leadership, safety • Hard to find: very specific, job-related skills Authoring Tools Self-Paced, Self-Service Online Learning • 24 X 7 X 365 access to courses • Completed at learner’s own pace • Remediation and feedback are automated • Developed once, used many times • Automated scoring and completion status • Custom development • Screen design and layout • Interactive exercises • Tests, Quiz, Assessment • Simulations • Central Access to Learning • Individualized Learning Plans • Reporting & Completion Tracking • Instructor-Led Training Scheduling • Launch and track online learning • Certification Management • Competency Management • Skill Gap Analysis • Archiving records • Automating Digital Signatures Learning Content Management Informal Learning, Knowledge On Demand • Manage large-scale development (workflow) • Reusable learning content • Searchable repository of source material • Just-in-time, anywhere, anytime • Capture and retain organizational knowledge • Facilitates collaboration

31. Informal Learning “Informal learning is simply that, which is not directed by an organization or somebody in a control position.” - Jay Cross

32. What about tacit knowledge? Tacit Knowledge • Identifying is difficult • Documenting is even more difficult Explicit Knowledge

33. Informal Learning Pfizerpedia

34. Sponsored by: Questions??? Facilitator: Bryan Chapman Chief Learning Strategist Chapman Alliance bryan@chapmanalliance.com EPA FDA SOX SEC OSHA

35. White Paper