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.

In this episode of the Veeva Training Solutions Podcast, Michelle Royals, Senior Director of Global QMS and Compliance at Veloxis Pharmaceuticals, shares her insights on the critical role of document control and training in establishing a solid Quality Management System (QMS). She emphasizes the importance of these components in ensuring compliance, efficiency, and consistency within life sciences organizations. Michelle provides practical tips on managing document revisions, integrating document management systems with learning management systems (EDMS & LMS), and fostering continuous improvement through audits and feedback. The views expressed by Michelle in this episode are her own and do not necessarily reflect the views of her company.

In this episode of the Veeva Training Solutions Podcast, experts discuss key steps for a successful software implementation, including securing early stakeholder buy-in, diagnosing inefficiencies in processes, people, or technology, and leveraging software to optimize workflows. They also cover how to define and track meaningful KPIs and offer tips for effective preparation, highlighting common pitfalls to avoid.