In this episode, Shad Ayoub, VP of Study Training Strategy at Veeva, discusses the evolution of clinical training, the unique features of Veeva's Study Training platform, and the future of standardized, purpose-built clinical training solutions.

In this episode, Graham sits down with Keyla Gonzalez, Manager of Learning and Development at Vericel, to pull back the curtain on L&D within a GxP environment. From the "SOP flood" facing new hires to the rare balance of LMS administration and creative instructional design, Keyla shares how her small team of three stays inspection-ready while prioritizing learner comprehension over simple compliance.

Joining us is Brian Drapeau of GxP Frame, author of “The CDMO Training Crisis.” In his recent piece, Brian outlines why traditional training models are breaking down in multi-client environments — and what it will take to fix them. We’ll explore why training is uniquely complex in CDMOs, how underinvestment creates a dangerous cycle of turnover and deviations, and what scalable training architecture really looks like in practice.

The conversation explores the transformative power of purposeful training, highlighting how leadership involvement can turn GxP education into a strategic imperative rather than a cost center. Karen provides unique insights into keeping teams engaged through innovative methods like gamification and explains how connecting training to real-world business outcomes, such as reducing the high costs of deviations and CAPAs, can secure top-down support. Whether you’re looking to modernize your current curriculum or drive better retention through job aids and manager reinforcement, this episode offers a blueprint for building a resilient, high-impact training program for 2026.

In this episode, Graham O’Keefe and Jonathan Menard of Agios Therapeutics Inc. discuss challenges and strategies for training in a virtual manufacturing environment. As a company without in-house labs or production, Agios Therapeutics Inc. transformed its training from 85% reliance on "read and understood" documents to a blended, engaging approach for departments like Quality, Supply Chain, and Clinical Operations. Key successes include implementing formal On-the-Job Training (OJT) in a virtual setting and developing a robust CTWG training matrix. Jonathan stresses that effective training relies on balancing consistency with flexibility through stakeholder collaboration.

Host Nina Ricciardelli and expert John Cheshire explore the shift from traditional, documentation-heavy CSV to a risk-based approach. This episode defines risk-based validation as an intelligent, targeted method focused on value, efficiency, and early identification of critical risks to enhance patient safety. They address common barriers like organizational culture and clarify that regulators emphasize validation goals over prescriptive documentation. The discussion also covers practical steps, like pilot schemes, for building confidence, necessary QMS adaptations, and the feasibility of risk-based validation even without dedicated digital tools. The core takeaway: begin by defining clear user requirements and intended system use.

Host Graham O'Keefe and guest John Constantine challenge the long-standing "read and understand" GxP training model. They argue for a shift from completion to competency, using creative analogies to advocate for visual, hands-on training. The conversation covers practical alternatives like simple videos and digital walkthroughs, and addresses major obstacles to change, such as ingrained industry culture and the need to update training SOPs. John concludes by emphasizing a "less is more" approach, focusing on essential content to reduce cognitive overload and accelerate employee readiness.

In this episode, Nina Ricciardelli of Veeva and guest Matt McMenamin from Sentinel Consulting Group explore the fundamental shift to digital validation. They discuss what it means to be truly data-centric, the critical cultural considerations for this transition, and the significant ROI achieved by moving beyond paper-based systems. Matt shares insights from his 30-year career, including his contributions to the new ISPE guide on digital validation and how connected ecosystems are transforming compliance and efficiency.

In this episode, Kristin Lambert discusses the crucial role of training and document control in clinical operations. She highlights the challenges of bridging the gap between research and quality mindsets, ensuring Part 11 compliance across platforms like informed consent and CDMO forms, and maintaining GCP consistency in global trials. The conversation explores the shift towards hybrid training, strategies for improving efficiency in SOP and TMF compliance, and key lessons learned in sustaining GxP compliance during onboarding and expansion. Kristin emphasizes the importance of collaboration and gaining buy-in from clinical teams to foster a strong quality culture and achieve effective training outcomes.