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/

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 Darnell

Expert 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 Duran

LearnGxP Links:

• Join our LinkedIn Community
• Join Veeva Connect
• Book 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-3068707
• US Food and Drug Administration: www.fda.gov
• Data Integrity and Compliance with CGMP: Questions and Answers Guidance for Industry, December 2018
• General Principles of Software Validation
• Check 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.uk

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/