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Four Faces of Compliance Training
- 1. 1Copyright © Veeva Systems 2018 The Four Faces of Compliance Training January 29, 2019 | 11:00 AM - 12:00 PM EST
- 2. 2Copyright © Veeva Systems 2018 Disclaimer This presentation is for informational purposes only and does not constitute legal or other professional advice. You should consult your own legal or compliance team before making a compliance decision. All information is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied. In no event will Veeva be liable to you or anyone else as a result of your use on this information.
- 3. 3Copyright © Veeva Systems 2018 John Constantine ORCHESTRALL John is a veteran of over 30 years in the life sciences industry, first at GlaxoSmithKline, then at Merck as Executive Director, Merck Polytechnic Institute in 2008, and joining Orchestrall, Inc. as Senior VP, Learning & Talent Solutions in 2016. His background includes Sales, Marketing, Corporate Staffs, Information Technology, Research and Development, and 25 years in Learning & Development. VEEVA SYSTEMS Kent has spent the majority of his career delivering technology-enabled training solutions to life sciences, holding leadership positions at industry leading companies such as AdMed, ClearPoint (Red Nucleus), UL EduNeering (UL), and now Veeva Systems. Kent Malmros
- 4. 4Copyright © Veeva Systems 2018 The Industry Perspective
- 5. 5Copyright © Veeva Systems 2018 One Problem, Three Perspectives • SOP & Policy training (role-based) • Part 11 compliant eSigs • Qualification and Compliance • Validation required • Reporting emphasis • First training adoption GxP Training HR TrainingCommercial Training • Mobile friendly (includes offline) • Engagement-focused • Launch and field readiness • Content-types expand • Compliance burdens change • Validation not necessary • Learning paths and competency • L&D orientation • More aligned with commercial • Overlap with compliance • Often own eLMS • HR-integration focus
- 6. 6Copyright © Veeva Systems 2018 Enabling the Life Sciences Digital Ecosystem Different content, delivered in different media types, organized by roles throughout different parts of the organization. EDMS GxP LMS CTMS HR LMS Meeting App Skype Web CRM Coaching Tool
- 7. 7Copyright © Veeva Systems 2018 Corporate Training Landscape
- 8. 8Copyright © Veeva Systems 2018 Training as a Part of Overall Compliance
- 9. 9Copyright © Veeva Systems 2018 Why does it matter? Training is the only way to demonstrate qualification What’s the impact of being out of compliance? Poor performance, quality events, inspection findings. What does the FDA look for? Gaps, oversight, overdue or general non-conformance Training as Part of Overall Compliance Efforts
- 10. 10Copyright © Veeva Systems 2018 Digging Deeper on Impact • Internal quality events with training impact • CAPA process oversight • Chasing your tail Investigation Findings Overall Impact Warning Letters and 483s • Inspections with training non- conformance lead to advisory actions by FDA • 483 lists specific observations • Easy to demonstrate compliance • Potential for large fines and business interruption • Inefficient business processes • Questionable product quality
- 11. 11Copyright © Veeva Systems 2018 The Four Faces of Compliance Training
- 12. 12Copyright © Veeva Systems 2018 10Copyright © Veeva Systems 2018 The Four Faces of Compliance Training Training Status Validated Systems Current and Correct Content Qualification-Driven Learner Roles Key takeaway: It’s not just about completing assignments on-time 10Copyright © Veeva Systems 2018 The Four Faces of Compliance Training Training Status Validated Systems Current and Correct Content Qualification-Driven Learner Roles Key takeaway: It’s not just about completing assignments on-time The Four Faces of Compliance Training Training Status Validated Systems Current and Correct Content Qualification-driven Learner Roles Key Takeaway: It’s not just about completing assignments on time
- 13. 13Copyright © Veeva Systems 2018 The Owners of Compliance Training Training Status: Learners, managers Validated Systems: Business process owners, IT Current and Correct Content: Subject matter experts, curriculum developers Qualification-Driven Learner Roles: Learning strategists, department heads, training Key Takeaway: It takes a village. Training is just the village chief
- 14. 14Copyright © Veeva Systems 2018 Digging Deeper: Each of the Four Faces
- 15. 15Copyright © Veeva Systems 2018 Training Status The Favorite Son
- 16. 16Copyright © Veeva Systems 2018 Training Status The Favorite Son KEY TAKEAWAY: Status is critical relative to events. There’s always a chance to get items completed and remediate. UNKNOWN Learners need to get the right stuff complete at the right time KNOWN MYTH INSIGHT The definition of overdue.Learner compliance can just as easily be derailed by lack of consumption clarity Status relative to job function is the key;
- 17. 17Copyright © Veeva Systems 2018 Validated Systems The Misunderstood Uncle
- 18. 18Copyright © Veeva Systems 2018 Validated Systems The Misunderstood Uncle KEY TAKEAWAY: Training system validation has tentacles; ensure you map the reach and identify any gaps. UNKNOWN GxP Training must be completed in a validated learning platform. KNOWN MYTH INSIGHT Any training content can be assigned through a validated learning platform Any connected part that is not validated jeopardizes the entire ecosystem Ensure any learning platform meets all critical components
- 19. 19Copyright © Veeva Systems 2018 Integration GxP LMS HR LMSDMS Controlled documents for quality and GxP training needs Manage GxP content and its assignment to users, as well as status Sync between DMS lifecycle states and actions in an LMS … Additional LMS most often used to assign and track other content … Validated Systems The Misunderstood Uncle
- 20. 20Copyright © Veeva Systems 2018 Current and Correct Content The Fickle Grandparent
- 21. 21Copyright © Veeva Systems 2018 Current and Correct Content The Fickle Grandparent KEY TAKEAWAY: Training content and derivative plans require their own periodic review schedule, exclusive of reviews driving source document review cycles UNKNOWN Controlled documents require retraining based on critical revisions KNOWN MYTH INSIGHT Non-GxP doesn’t share the same burden of review and currency Content changed based on agency guidance updates share the same burden Ensuring you have the right content is a balance.
- 22. 22Copyright © Veeva Systems 2018 Qualification-driven Learner Roles The Millennial Nephew
- 23. 23Copyright © Veeva Systems 2018 Qualification-driven Learner Roles The Millennial Nephew KEY TAKEAWAY: Monitoring training status at a granular learner role level allows you to deliver the right content to the right people at the right time UNKNOWN We need to be concerned about under-training KNOWN MYTH INSIGHT Learner roles are not necessarily linked strictly to someone’s job description The agency is increasingly concerned about over- training Well-developed learner roles are the pivot point
- 24. 24Copyright © Veeva Systems 2018 R&D Regulatory Manufacturing Quality Qualification-driven Learner Roles The Millennial Nephew
- 25. 25Copyright © Veeva Systems 2018 Making the Family Less Dysfunctional
- 26. 26Copyright © Veeva Systems 2018 Making the Family Less Dysfunctional
- 27. 27Copyright © Veeva Systems 2018 Making the Family Less Dysfunctional Training Status: Put status reports in the hands of managers Validated Systems: Move towards a single unified system Current and Correct Content: Coordinate periodic review of source and training content Qualification-Driven Learner Roles: Build learning path based on micro-curricula Unifying Thought: Choose one challenge at a time.
- 28. 28Copyright © Veeva Systems 2018 John Constantine john.constantine@orchestrallinc.com Kent Malmros kent.malmros@veeva.com
Editor's Notes
- MARKETING
- We designed this webinar to talk about compliance-related training, and how to best consider it holistically for your organization. But it starts with a brief reminder around what exactly compliance training is… Compliance training refers to the process of educating employees on laws, regulations and company policies that apply to their day-to-day job responsibilities. In our world, with Life Sciences among the most highly regulated industries in the world, that has the potential to mean all training efforts have a compliance impact.
- KENT That’s why Life Sciences training isn’t simple Most corporate training serves a less complicated master, and while the concepts are the same, the regulator--compliance landscape means that three top-level stakeholder groups – GxP, Commercial Training and HR Training simply have different critical requirements. GxP :: Part 11 compliant eSigs, validated systems, audit trail, this is often where people isolate their thinking of compliance-related training. But, it goes beyond that. Commercial :: Point of learning (field), events, requirement to hit gates. And commercial stakeholders are often required to consume SOPs with a compliance impact. And, in the strict sense of the word HR :: learning paths for prof dev
- KENT We tend to lose sight of this overarching theme, however, because the Interestingly, LS companies GROW through training needs in that order The problem is, organizations don’t typically do it in a linear fashion While GxP training is needed first, the fast follow nature of HR/Commercial can happen with immense speed This means each group often does what’s needed to meet its own needs Multiple systems are procured and fragmentation happens quickly
- KENT The picture gets complicated quickly. LS companies need sound resources for training content and digital training delivery and management. In an industry where training is a critical part of overall compliance health, this rapid breakdown causes tremendous problem and… contributes to challenges associated with each of the four face of training compliance. When the picture looks like this, it likewise compromises the processes that support training.
- So we know compliance training is complicated, requires attention and constant re-evaluation. Why? Well, it’s also important to remember how training fits into the overall compliance health of an organization… and how overlooking any of the issue we’re talking about today can impact a companies overall compliance.
- JOHN
- JOHN
- KENT So how do you get there? Too often, John and I have seen (on both sides of the problem) a single-threaded or maybe double-threaded view of training compliance. Unfortunately, anything less than a holistic view puts your organization at risk So, what are the four?
- KENT Part of the reason its so hard to look at them all concurrently, is because they typically have different owners, influencers and stakeholders…
- Training Status: The Favorite Son (John) Known: Learners need to get the right stuff complete at the right time Unknown: Learner compliance can just as easily be derailed by lack of consumption clarity Myth: The definition of overdue. When you join a typical company, you get huge volume of training (80-100 tasks) that are due within 30 days; why? What the business driver that creates that problem. Companies feel they are in compliance because they ARE NOT overdue (not necessarily true; can have all the boxes checked but not be compliant) Insight: Status relative to job function is the key; learning plans can be built to use overdue as a reminder, not an end state Key takeaway: Status is critical relative to events. There’s always a chance to get items completed and remediate.
- Training Status: The Favorite Son (John) Known: Learners need to get the right stuff complete at the right time Unknown: Learner compliance can just as easily be derailed by lack of consumption clarity Myth: The definition of overdue. When you join a typical company, you get huge volume of training (80-100 tasks) that are due within 30 days; why? What the business driver that creates that problem. Companies feel they are in compliance because they ARE NOT overdue (not necessarily true; can have all the boxes checked but not be compliant) Insight: Status relative to job function is the key; learning plans can be built to use overdue as a reminder, not an end state Key takeaway: Status is critical relative to events. There’s always a chance to get items completed and remediate.
- Computer Systems Validation (CSV) is a process used to ensure (and document) that a computer-based systems will produce information or data that meet a set of defined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. One of the very FDA regulations on which we train is 21 CFR Part 11 which governs that training records are maintained in a validated learning platform. So we need training platfor Validated System: The Misunderstood Uncle (Kent) Known: GxP Training must be completed in a validated learning platform. Unknown: Any connected part that is not validated (middleware, connector, etc.) jeopardizes the entire ecosystem Myth: Any training content (commercial, HR, etc.) can be assigned through a validated learning platform Insight: Ensure any learning platform meets all critical components: validation support or readiness (IQ/OQ); audit trails and Part 11 compliance eSignatures Key takeaway: Training system validation has tentacles; ensure you map the reach and identify any gaps
- Validated System: The Misunderstood Uncle (Kent) Known: GxP Training must be completed in a validated learning platform. Unknown: Any connected part that is not validated (middleware, connector, etc.) jeopardizes the entire ecosystem Myth: Any training content (commercial, HR, etc.) can be assigned through a validated learning platform Insight: Ensure any learning platform meets all critical components: validation support or readiness (IQ/OQ); audit trails and Part 11 compliance eSignatures Key takeaway: Training system validation has tentacles; ensure you map the reach and identify any gaps
- Myth – validation is burdensome, so we will only validate the system that contains GxP content. This creates more chaos, cost, and user burden than having one single validated system.
- Current and correct content: The Fickle Grandparent (John) Known: SOPs, Policies and Procedures require retraining based on critical revisions Unknown: Standard content libraries changed based on agency guidance updates share the same burden Myth: Non-GxP doesn’t share the same burden of review and currency Insight: Ensuring you have the right content is a balance between internal policies and procedures, as well as changing regulatory compliance oversight Key takeaway: Training content and derivative plans require their own periodic review schedule, exclusive of reviews driving source document review cycles
- Current and correct content: The Fickle Grandparent (John) Known: SOPs, Policies and Procedures require retraining based on critical revisions Unknown: Standard content libraries changed based on agency guidance updates share the same burden Myth: Non-GxP doesn’t share the same burden of review and currency Insight: Ensuring you have the right content is a balance between internal policies and procedures, as well as changing regulatory compliance oversight Key takeaway: Training content and derivative plans require their own periodic review schedule, exclusive of reviews driving source document review cycles
- Qualification-driven learner roles: The Millenial Nephew (Kent) Known: We need to be concerned about under-training Unknown: The agency is increasingly concerned about over-training Myth: Learner roles are not necessarily linked strictly to someone’s job description Insight: Well-developed learner roles are the pivot point between content-drive compliance and status-based compliance Key takeaway: Monitoring training status at a granular learner role level allows you to deliver the right content to the right people at the right time
- Qualification-driven learner roles: The Millenial Nephew (Kent) Known: We need to be concerned about under-training Unknown: The agency is increasingly concerned about over-training Myth: Learner roles are not necessarily linked strictly to someone’s job description (NOTE: Modify this myth to the be the techn mismatch between metadata on docs, and role-based training) Insight: Well-developed learner roles are the pivot point between content-drive compliance and status-based compliance Key takeaway: Monitoring training status at a granular learner role level allows you to deliver the right content to the right people at the right time
- Training roles for function, site, etc.
- LEGAL DISCLAIMER SLIDE