• 12: Disrupting the Paradigm

  • Nov 13 2022
  • Length: 56 mins
  • Podcast

12: Disrupting the Paradigm

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  • Summary

  • This episode originally aired on September 14th, 2021

    This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next.

    Resources from this episode:
    One Voice of Quality Website - https://prst.ie/1vq/ 
    One-Voice-of-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT - https://www.ivtnetwork.com/article/one-voice-quality-1vq-solutions-part-2-podcast-episode
    One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ... - https://www.ivtnetwork.com/article/one-voice-quality-1vq-solutions-%E2%80%93-enhanced-science-and-risk-based-approach-post-approval-cha
    Elon Musk Hiring Ad - https://www.cnbc.com/2020/02/03/elon-musk-is-recruiting-for-tesla-education-is-irrelevant.html 
    What Is Industry 4.0? - https://www.youtube.com/watch?v=yKPrJJSv94M&t=1s
    ISPE Pharma 4.0 initiative - https://ispe.org/initiatives/pharma-4.0

    About Our Guest:
    Karen Ginsbury
    Karen is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics.
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