Fireside Chat Series: Adding Standard Modules to Your Training Matrix - Video 4 of 7

This video, part of a fireside chat series hosted by Veeva Systems, provides an in-depth discussion on the strategic challenges and best practices for integrating standardized e-learning content libraries into the existing training matrices and Quality Management Systems (QMS) of life sciences organizations. Featuring Kent Malmros, Senior Director of Vault Training at Veeva Systems, and Graham O'Keeffe, Founder and CEO of Learnaboutgmp, the conversation emphasizes that simply licensing a large content library is insufficient; the true value lies in the consultative effort required to align that content with internal Standard Operating Procedures (SOPs) and regulatory requirements. The speakers address the common challenge faced by emerging life sciences organizations, which typically start with training based solely on internal documentation (SOPs, work instructions) and then become overwhelmed when introducing a vast, generic content library.

The core methodology advocated by the speakers centers on a deep, consultative understanding of the client's business and QMS structure. Graham O'Keeffe stresses that training departments must move beyond a superficial overview and possess a deep understanding of how the QMS functions, what drives SOP creation (e.g., regulation, work practice), and how to align external content with those drivers. This requires an initial phase of discovery and ongoing, agile strategy calls (often weekly) to ensure the training strategy remains current and adapts to changing regulations or business needs. The complexity of this alignment process necessitates specialized consultancy, focusing on different facets of the business like data integrity, contamination control, or validation.

A critical insight shared is the necessity of tailoring content delivery based on the audience's role and need, rather than adopting a "one-size-fits-all" approach. Using the example of a global data integrity awareness program rollout, O'Keeffe explains that different levels of courses were created: an introductory course for manufacturing line personnel and more advanced courses for roles working directly with data, such as those in validation. This segmented approach ensures that employees can actually consume and digest the relevant information, maximizing the effectiveness of the training. The speakers conclude by proposing a "perfect triangle" partnership model involving the best-of-breed Learning Management System (LMS) provider (like Veeva Vault Training), the best-of-breed content provider (who offers consultative support), and the internal training department focused on day-to-day SOP and QMS training items.

Key Takeaways: • Consultative Content Integration is Essential: Licensing a content library is only the first step; successful integration requires deep consultancy to understand the client's QMS, business processes, and regulatory drivers to effectively map external content to internal SOPs and work instructions. • Deep Business Understanding is Required for Training Staff: Personnel responsible for training matrices must possess an in-depth understanding of the business operations and how the QMS works, including what triggers the creation or update of an SOP (e.g., a specific regulation, a quality event, or a new work practice). • Agile Strategy is Necessary for Compliance: Training strategy alignment should not be a one-time event. Content providers and training departments must engage in ongoing, agile strategy calls (potentially weekly) to update modules and content rapidly when regulations change or business needs evolve. • Avoid the "One-Size-Fits-All" Pitfall: Training programs must be segmented and tailored to the audience. For example, a data integrity awareness program should offer different courses (introductory vs. advanced) for personnel on the manufacturing line versus those in validation or data management roles. • Align Broad Regulatory Guidance with Internal Processes: When introducing broad regulatory content (e.g., "Intro to GxP"), organizations must collaborate between the external regulatory content expert and the internal business process owner to evolve the training matrix and ensure alignment with specific internal guidelines for creating quality documents or assays. • The "Perfect Triangle" Partnership Model: Optimal training success is achieved through a three-way partnership: a best-of-breed LMS provider (e.g., Veeva Vault Training), a best-of-breed content provider who offers consultative support (like Learnaboutgmp), and the internal training department managing SOP-based training. • Leverage Content Vendor Expertise: Companies should select content vendors who partner with customers to understand how the content will be used, not just those who provide aesthetically pleasing content. This consultative partnership is a critical differentiator for successful training deployment. • Co-mingle Content Effectively: The training matrix must effectively co-mingle internal documents (SOPs) and external e-learning modules (like "Good Documentation Practices"), applying consistent training rules regarding retraining frequency and mandatory updates following quality actions or events.

Tools/Resources Mentioned:

• Veeva Vault Training: A specific product within the Veeva Systems ecosystem used for managing training, QMS, and content.
• Learnaboutgmp: A content provider specializing in GxP and regulatory e-learning content.

Key Concepts:

• GxP (Good Practices): A set of quality guidelines and regulations applicable to the pharmaceutical and life sciences industries (e.g., Good Manufacturing Practices).
• QMS (Quality Management System): The formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Training Matrix: A structured plan or document that maps specific training requirements (courses, SOPs) to specific job roles or personnel groups within an organization.
• Data Integrity: The assurance that data is accurate, consistent, and complete throughout its lifecycle, a critical regulatory focus area.

Examples/Case Studies:

• Global Data Integrity Awareness Program: A recent project where the content provider (Learnaboutgmp) rolled out a data integrity program that included six different courses. The program was segmented to provide an introductory course for line personnel and more advanced courses for staff in validation or other data-intensive manufacturing roles, demonstrating the necessity of audience-specific tailoring.