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Presenter:Karen Taylor (née Ginsbury) is a GMP and Quality Management Systems consultant with over 30 years of industry experience. She has supported both large and small start-up companies in regulatory inspection readiness, handling, and post-inspection responses. Having conducted hundreds of CDMO audits, Karen brings a wealth of case studies to share with participants. Formerly active […]
This forward-looking discussion dives into how AI is transforming validation workflows in the medical device space. Discover how companies are using machine learning and automation to drive speed, accuracy, and regulatory compliance—all without compromising quality. Tune in for actionable insights that will prepare you to integrate digital solutions into your validation process. What You’ll Gain: […]
Moderator: Marsha Steed, President, Steed MicroBio Panelists:Elizabeth Brockson, Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology, TakedaParsa Famili, President and CEO, Novatek International Avoid the most frequent and costly missteps in contamination control during this no-slides-needed webcast. In this practical conversation, we break down the most common microbial contamination failures and […]
Published By VTI Life Sciences Introduction The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) systems must […]
Reshma Kodumuru, Principal CSV, KBI BioPharma Abstract With the rapid rate of digital change nowadays, ensuring data is secure and intact across complicated systems is the biggest challenge for the pharmaceutical industry. Government agencies such as the FDA, EMA, MHRA, and ICH all emphasize that trustworthy data, being complete, consistent, and accurate, is the foundation […]
