Fireside Chat Series: Managing Updates and Re-Training - Video 5 of 7

This video, part of Veeva Systems' "Fireside Chat Series," features Kent Malmros, Senior Director of Vault Training at Veeva Systems, and Graham O'Keeffe, Founder and CEO of Learnaboutgmp. The discussion centers on the critical and often challenging process of managing updates and ensuring timely retraining for e-learning content libraries, particularly within the highly regulated life sciences industry. Malmros initiates the conversation by highlighting Veeva's entry into the training technology space, driven by the historical difficulty and cost associated with connecting regulated document management systems with third-party learning management systems (LMS) to ensure automatic and compliant retraining on updated control documents. This challenge extends beyond internal documents to external e-learning libraries, such as an "introduction to GMP course," which also require diligent management and retraining triggers when content changes.

O'Keeffe then details Learnaboutgmp's multi-faceted approach to keeping their e-learning libraries current and aligned with evolving regulations, guidelines, and standards. His methodology involves a three-phased strategy: first, an in-house QA team dedicated to monitoring and tracking regulatory updates relevant to their course library; second, monthly consultations with subject matter experts (SMEs) who are inherently abreast of industry changes; and third, weekly calls with clients to proactively understand upcoming regulatory shifts and industry needs. He cites the example of the new EU Medical Device Regulation (EU MDR), for which Learnaboutgmp began production of an online program eight months in advance, demonstrating a proactive stance driven by direct client engagement. This consultative approach, particularly the consistent weekly client contact, is presented as a unique and highly effective strategy, contrasting with the more isolated content update processes often seen in other e-learning providers.

The conversation further explores the communication aspect of content updates. O'Keeffe explains that Learnaboutgmp utilizes internal communication mechanisms to inform clients about course updates, regulatory changes, and which specific courses have been affected. This agile communication, coupled with responsive customer service, ensures that clients are not only aware of changes but also understand how to process them and identify who needs to be retrained. The speakers emphasize that having up-to-date, expert content is only valuable if customers know it exists and how to effectively deploy it. The agility and strong communication capabilities in redeploying new assets are highlighted as critical differentiators, ensuring customers can quickly adapt to regulatory shifts and maintain compliance. The discussion concludes by hinting at future topics, such as managing updates for smaller micro-learning assets, underscoring the ongoing complexity of content lifecycle management in regulated environments.

Key Takeaways:

• The Challenge of Regulated E-Learning Updates: Life sciences companies face significant hurdles in managing updates and retraining for e-learning content, especially when it's tied to industry regulations. Historically, connecting regulated document management systems with third-party LMS for automated, compliant retraining has been costly and time-consuming, a problem Veeva aims to solve with its training technology.
• Proactive Regulatory Monitoring is Essential: Effective content providers in regulated industries must employ proactive strategies to monitor regulatory changes. Learnaboutgmp, for instance, uses an in-house QA team and monthly SME consultations to stay abreast of updates to regulations, guidelines, and standards, ensuring content remains current.
• Client-Centric Content Strategy Drives Relevance: Engaging directly with clients on a consistent basis (e.g., weekly calls) is crucial for understanding their evolving needs and anticipating major regulatory shifts. This allows content providers to proactively develop or update training programs, as demonstrated by Learnaboutgmp's early development of an EU MDR program based on client input.
• Importance of Deep Subject Matter Expertise: Content providers must possess or have access to deep subject matter expertise to ensure their e-learning materials are accurate, current, and compliant with the latest industry standards and regulations, which is a key differentiator for quality.
• Agile Content Development and Deployment Capabilities: The ability to quickly update and republish new versions of e-learning courses is essential for maintaining compliance in dynamic regulatory environments. This agility extends to the proactive development of new programs in anticipation of significant regulatory changes.
• Robust Communication Mechanisms for Updates are Critical: It's not enough to simply update content; providers must have clear internal communication mechanisms to inform clients about changes, including which regulations have been affected and which courses have been revised. This ensures clients know what has changed and why.
• Guidance on Retraining Triggers and Implementation: Content providers should assist customers in understanding how to process updates, who should be retrained, and when. This backend support is critical for customers to effectively utilize updated content for compliance purposes and manage their workforce training.
• Customer Service as a Key Differentiator: Responsive customer service that provides instant feedback and facilitates quick changes is vital in a fast-moving regulatory environment. This enables clients to reach out and get immediate support regarding content updates and deployment, enhancing the overall value proposition.
• The Value of Up-to-Date and Actionable Content: Expert, up-to-date content is only valuable if customers are aware of its existence and know how to effectively use and deploy it within their organization. Strong communication capabilities are hyper-critical for ensuring content translates into actionable compliance.
• Anticipating Major Regulatory Shifts with Clients: Successful content providers work collaboratively with clients to identify and prepare for major regulatory changes, such as the EU MDR, ensuring workforces are trained and ready before new regulations come into effect to avoid operational disruptions and maintain market access.

Tools/Resources Mentioned:

• Veeva Vault Training: A specific product from Veeva Systems designed to manage training within regulated industries, highlighted as a solution for connecting regulated document management with learning management systems.
• Learning Management System (LMS): A general term for software applications used to administer, document, track, report, and deliver educational courses or training programs.

Key Concepts:

• Regulated Document Management System: A system used by organizations in regulated industries (e.g., life sciences) to control and manage documents that are subject to regulatory requirements, ensuring compliance and auditability.
• GMP (Good Manufacturing Practice): A system of quality standards that ensures products are consistently produced and controlled according to quality standards, minimizing risks in pharmaceutical production.
• EU MDR (European Union Medical Device Regulation): A comprehensive regulation governing the production and distribution of medical devices in the EU, emphasizing higher safety and performance standards.
• SLA (Service Level Agreement): A contractual commitment between a service provider and a customer outlining the expected level of service, including aspects like content updates and delivery timelines.
• Micro-learning Assets: Small, focused units of learning content designed for quick consumption and addressing specific learning objectives, mentioned as a future topic for continuous updates.

Examples/Case Studies:

• EU Medical Device Regulation (EU MDR): Learnaboutgmp proactively started developing an online training program for the EU MDR approximately eight months before its implementation, based on ongoing discussions with multinational medical device companies. This demonstrates how client engagement drives the anticipation and preparation for significant regulatory changes.
• Introduction to GMP Course: This is used as a specific example of an e-learning library course that requires regular updates and triggered retraining when its content changes due to evolving regulations, highlighting the ongoing challenge of content lifecycle management.