Veeva Training Solutions Podcast

Епизоди

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  Doing More with Less: The GxP Training Survival Guide for Small Teams 15.04.2026 20мин

  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.
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  The CDMO Training Crisis 12.03.2026 20мин

  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.
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  Building a Culture of GxP Excellence in 2026 30.01.2026 10мин

  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.
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  Veeva Study Training: Redefining the Clinical LMS 16.07.2026 14мин

  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.
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  Strategic GxP Training for Virtual Manufacturing 25.11.2025 20мин

  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.
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  From Paper Piles to Precision: Solving the CSV Puzzle 16.10.2025 16мин

  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.
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  Rethinking GxP Training: Competence Rather than Completion 04.08.2025 19мин

  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.
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  Optimizing Validation: Embracing the Digital, Data-Centric Future 16.06.2025 17мин

  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.
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  Bridging the Gap Between Clinical Training and GxP Compliance 15.05.2025 11мин

  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.
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  Compliance Unlocked: Mastering Document Control & Training 27.03.2025 12мин

  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.
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  The Foundation of Software Implementation: Essential Steps for a Smooth and Successful Deployment 26.02.2025 17мин

  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.
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  How Hands-on Training is Shaping Modern GMP Manufacturing 07.01.2025 22мин

  In this episode, we delve into the world of hands-on manufacturing training with Justin Cook, the Chief Technical Officer at Sequence. We explored the benefits of their state-of-the-art training facility, which empowers employees with practical skills and knowledge. By aligning with FDA guidelines and integrating hands-on training with other learning modalities, Sequence ensures that their workforce is well-prepared to meet the challenges of modern manufacturing.
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  Rethinking Training and Development 07.01.2025
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  Fixing Our Read and Understand Problem: The True Challenge 28.10.2024 21мин

  Tired of ineffective Read and Understand training? This episode explores why traditional "Read and Understand" methods often fail. Join us as we discuss the limitations of current approaches and discover innovative strategies for modern learning. Our expert guest, Christian Torstensson, shares insights on how to transform your organization's training and unlock the full potential of your workforce.
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  Beyond the Score: A Guide to Creating Effective Assessments in the Life Science Industry 17.09.2024 21мин

  In this episode, we explore the intricacies of creating effective assessments in the life sciences. With expert guidance from Steven Just, learn how to design fair, valid, and reliable assessments that accurately measure learning outcomes. Discover strategies for crafting high-quality questions, setting appropriate passing scores, and leveraging AI for innovative measurement.
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  Systems in Silos: The Inefficiency of Managing Disparate DMS and LMS 19.11.2024 19мин

  This episode explores the hidden challenges of using separate Document Management Systems (DMS) and Learning Management Systems (LMS). We discuss the administrative burden, impact on efficiency, and hidden costs associated with maintaining these disconnected systems. Brittany Recker, Senior Manager, Quality Systems at Astria Therapeutics, shares her experiences and the benefits of a unified training, content, and documentation solution.
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  Boost Your Training ROI: 3 Critical Factors for Choosing the Right Vendor 12.08.2024 15мин

  Selecting the right training vendor is crucial. This episode reveals hidden factors beyond cost and features. Learn how implementation, information, and innovation impact your training program's success.
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  The Benefits of Adopting the Quality Management Maturity (QMM) Program 30.05.2024 24мин

  In this episode, we uncover the origins of the FDA's Quality Management Maturity (QMM) program, born from a 2019 task force report on supply chain disruptions. With 62% of drug shortages linked to manufacturing and quality issues, and hospitals facing over $350 million in annual costs, the urgency for QMM is clear. We explore how QMM not only offers significant cost savings but also enhances patient care. Dive into the FDA's three-step approach, from CGMP compliance to ICH Q10, and its four core elements. Despite these benefits, why is the industry hesitant to advance its quality systems? We examine the market dynamics and economic pressures behind this reluctance and the critical need for regulatory intervention. Join us to discover QMM's transformative potential and its profound impact on the future of the pharmaceutical industry.
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  Evolving Excellence: The Training Maturity Model with Danielle Duran 02.05.2024 17мин

  What if your training programs could do more, achieve more? In this episode, Graham unlocks the secrets of "Fit-for-Purpose Training" with Danielle Duran. Explore how to ditch generic training and design programs that deliver real results. Dive into powerful maturity models and the four-pillar framework that sets your training up for success.
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  Navigating the Top 5 Risks of Data Integrity with Jacqueline Herlihy 23.04.2024 16мин

  Join Graham and Jacqueline in examining the paramount significance of data integrity within the life sciences sector. They will delve into the top five risks, and then some, while also discussing effective strategies for their management within GxP systems. From potential human errors to the validation of software, gain invaluable insights to bolster your data integrity protocols and guarantee adherence to regulatory standards in this tightly regulated domain.