Fireside Chat Series: Five Steps for Implementing an Effective eLearning Program - Video 7 of 7

This fireside chat, featuring Kent Malmros, Senior Director of Vault Training at Veeva Systems, and Graham O'Keeffe, Founder and CEO of Learnaboutgmp, provides a structured framework for life sciences companies to rapidly and effectively implement digital learning programs, particularly in the context of a dispersed, post-pandemic workforce. The discussion emphasizes that e-learning has become a critical, permanent tool for compliance and upskilling, necessitating a strategic, technology-supported approach rather than ad-hoc deployment. The speakers detail a five-step methodology for transitioning traditional training departments to a robust online model, focusing heavily on regulatory alignment, content development ownership, and knowledge retention techniques.

The core of the discussion revolves around O'Keeffe's five actionable steps for implementation. The first step involves defining a comprehensive learning strategy by assessing capability gaps, aligning training goals (short-term vs. long-term) with overall business strategy, and critically reviewing the Quality Management System (QMS) and associated Standard Operating Procedures (SOPs) to define required course content. This foundational alignment ensures that all training efforts directly support regulatory compliance and operational excellence. Following strategy definition, the second step focuses on course development, stressing the importance of leveraging internal Subject Matter Experts (SMEs) to create content, ensuring rigorous second and third reviews to align with regulations and standards, and formalizing the course creation process.

A significant portion of the conversation is dedicated to the third step: implementing a microlearning approach for reinforcement. The speakers advocate for short, 45-to-60-second videos deployed regularly to increase knowledge retention, contrasting this with traditional, lengthy 45-to-60-minute annual courses. This strategy is presented as a vital countermeasure to modern challenges like "Zoom fatigue," keeping the dispersed workforce engaged and ensuring critical business areas receive timely information. The fourth step addresses customization, urging companies to build internal capabilities to tailor courses to their specific business procedures, not just generic regulations. This customization is essential for global companies seeking to harmonize training across different regions. Finally, the fifth, often-overlooked step is defining an internal marketing strategy to promote the training. The goal is to generate excitement and awareness around mandatory compliance training and optional upskilling courses, ensuring high engagement and utilization.

Malmros reinforces the necessity of technology to enable these five steps, particularly highlighting the need for flexible e-learning platforms (like Veeva Vault Training) that can easily manage training matrices and update content rapidly. He strongly advises against relying solely on external content providers, echoing O'Keeffe's point that organizations must take ownership of their learning programs and build internal expertise, including mastering external, specialized authoring tools rather than expecting the Learning Management System (LMS) to contain a proprietary authoring function. This collaborative expertise—combining robust technology with internal content ownership—is positioned as the key to becoming a successful, agile learning organization in the regulated life sciences sector.

Key Takeaways:

• Strategic Alignment is Paramount: The initial step in digital learning implementation must be defining a clear learning strategy that identifies capability gaps and aligns directly with the business strategy, short/long-term goals, and the requirements dictated by the Quality Management System (QMS) and SOPs.
• QMS and SOP Review: Training content must be directly derived from and aligned with the organization's existing SOPs and regulatory requirements (GxP, standards), ensuring that the training program serves as a verifiable component of the compliance framework.
• Internal SME Content Ownership: Life sciences companies should prioritize building internal expertise and leveraging Subject Matter Experts (SMEs) to author and develop course content, rather than outsourcing all content creation. This ensures accuracy, regulatory alignment, and the ability to rapidly update materials.
• Rigorous Review Process: All developed content must undergo a stringent review process (second and third reviews) to guarantee alignment with both external regulations and internal procedures before deployment.
• Microlearning for Retention: Implement a microlearning approach using short, high-impact assets (e.g., 45-60 second videos) to reinforce knowledge retention, especially for critical business areas, counteracting the low retention rates associated with long-form annual courses.
• Combatting Fatigue: Microlearning assets are crucial for maintaining engagement and combating "Zoom fatigue" in a remote or dispersed workforce, making training accessible and less time-consuming.
• Customization for Procedure Alignment: Organizations must have the capability to customize and tailor courses to align specifically with their unique internal procedures and business operations, going beyond generic regulatory standards.
• Global Harmonization: For global pharmaceutical companies, customization capabilities are essential for harmonizing training content and delivery across different international sites and regulatory jurisdictions.
• Promote Training Internally: Define and execute an internal marketing strategy to promote both mandatory compliance training and optional upskilling courses. This is necessary to drive engagement, excitement, and awareness, ensuring high adoption rates.
• Technology Enables Flexibility: The chosen e-learning technology (LMS/Veeva Vault Training) must be flexible enough to easily manage and rapidly change the training matrix as the organization's learning strategy evolves, which is particularly vital for emerging pharma companies.
• Separate Authoring Tools: Companies should invest in best-of-breed, specialized external authoring tools and build internal expertise around them, rather than relying on or expecting the LMS platform to provide a comprehensive, integrated authoring solution.
• Take Ownership of the Program: Organizations must take full ownership of their learning program strategy and execution, recognizing that digital learning is a permanent, forward-moving necessity for a dispersed workforce and regulatory adherence.

Tools/Resources Mentioned:

• Veeva Vault Training
• Learning Management Systems (LMS)
• External Authoring Tools (recommended but not named specifically)

Key Concepts:

• Microlearning: A strategy involving the delivery of content in small, focused bursts (e.g., 45-60 second videos) designed to aid knowledge retention and provide quick reinforcement, particularly effective for compliance topics.
• GxP/Regulatory Alignment: Ensuring that all training content and processes adhere to Good Practices (e.g., GMP, GCP, GLP) and other regulatory standards mandated by bodies like the FDA and EMA, often tracked via the QMS and SOPs.
• Zoom Fatigue: The exhaustion and disengagement resulting from excessive reliance on video conferencing and long online sessions, which microlearning seeks to mitigate.
• Training Matrix: The structured framework within an LMS that defines which employees require specific training courses based on their role, location, and regulatory requirements.