Episodios
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Description: 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.
Expert: Peter Alcocer, Director of eLearning Compliance at Veeva LearnGxP
LearnGxP Links:
Join LinkedIn Community: https://www.linkedin.com/company/learngxp/
Join Veeva Connect: https://veevaconnect.com/communities/ANhQ3gFSkAA/about?join=1
Book a Demo: https://learngxp.com/book-a-demo/
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¿Faltan episodios?
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Want to dive deeper into the Maturity Model approach and fit-for-purpose training? Tune in to our upcoming webinar with Danielle on May 29th. She'll cover real-world applications, from aligning stakeholders on current-state maturity to advancing levels. Don't miss out— REGISTER HERE!
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The views expressed by Danielle in this episode are her own and do not necessarily reflect the views of her company.
Description: In this episode, Graham explores the concept of Fit-for-Purpose Training with Danielle Duran, a life sciences Learning & Development expert. They discuss what it means to have fit-for-purpose training programs, how maturity models can be used to evaluate and improve training programs, and the four pillars of a successful training program.
Expert: Danielle Duran
Links Mentioned in the Episode:
Webinar: Fit-for-Purpose Training Webinar - Register Here!LTEN Article: “Fit-for-Purpose: Training Program Maturity”Veeva LearnGxP Podcast (Ep. 7): Learning Reimagined: Your Guide to the Changing Talent Development Landscape with Brook DarnellExpert Links:
LinkedIn: https://www.linkedin.com/in/danielleduran/Previous Podcast Episode - Veeva LearnGxP Podcast (Ep. 4): The Secret to Effective Training in the Life Science Industry with Danielle DuranLearnGxP Links:
Join our LinkedIn CommunityJoin Veeva ConnectBook a Demo -
Description: Join Graham and Jacqueline as they delve into the critical importance of data integrity in the life sciences industry, exploring the top 5 risks (plus a few more!) and strategies for managing them within GxP systems. From human error to software validation, learn key insights to fortify your data integrity practices and ensure compliance in this highly regulated landscape.
Expert: Jacqueline Herlihy, Principal Consultant at Herlihy Consulting, LLC
Expert Links:
www.linkedin.com/in/jacqueline-herlihy-3068707US Food and Drug Administration: www.fda.govData Integrity and Compliance with CGMP: Questions and Answers Guidance for Industry, December 2018General Principles of Software ValidationCheck to ensure using the most recent version of a guidance on this website: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm Medicines and Healthcare products Regulatory Agency: www.gov.ukLearnGxP Links:
Join LinkedIn Community: https://www.linkedin.com/company/learngxp/
Join Veeva Connect: https://veevaconnect.com/communities/ANhQ3gFSkAA/about?join=1
Book a Demo: https://learngxp.com/book-a-demo/
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Description: Join us for an enlightening conversation with Shauna Greene, a passionate expert in compliance training. Shauna shares her insights into creating a culture of quality through innovative training methods. She introduces "Coffee and Compliance," a weekly microlearning initiative designed to keep learners engaged with regular, bite-sized content. By focusing on the 'why' behind training and incorporating interactive elements, Shauna builds a culture where learners eagerly anticipate and actively participate in their development.
Throughout the episode, Shauna highlights the importance of holistic training approaches, branded marketing themes, and the 'what's in it for me' mindset to enhance engagement and motivation. She shares success stories, including achieving 100% training compliance through refresher courses tailored to put learners in the driver's seat. Looking ahead, Shauna discusses upcoming focus areas such as GDPR, data integrity, and inspection readiness, emphasizing the critical role of compliance across all levels of the organization.
Don't miss this insightful discussion on making compliance training not only effective but also engaging and impactful.
Expert: Shauna Greene, Associate Director Training & Document Management at Recipharm
Expert Links:
LinkedIn:http://linkedin.com/in/shaunagreene023
LearnGxP Links:
Join LinkedIn Community: https://www.linkedin.com/company/learngxp/
Join Veeva Connect: https://veevaconnect.com/communities/ANhQ3gFSkAA/about?join=1
Book a Demo: https://learngxp.com/book-a-demo/
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Description: Discover how Veeva Training Solutions revolutionize traditional methods, addressing challenges like disjointed processes and ineffective assessments. Through a unified approach, we streamline processes, enable data-driven decision-making, and empower organizations for success. Explore our three pillars: Content, Technology, and People, driving efficiency and personalized support. Real-world examples highlight positive impacts, while our unified approach fosters community collaboration. Learn about the future of training solutions in life sciences and Veeva's commitment to innovation.
Expert: Kent Malmros
LearnGxP Links:
Join LinkedIn Community: https://www.linkedin.com/company/learngxp/
Join Veeva Connect: https://veevaconnect.com/communities/ANhQ3gFSkAA/about?join=1
Book a Demo: https://learngxp.com/book-a-demo/
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