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 […]
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 […]
Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]
Andrea Roether, Senior Director of Global Quality, Creation Technologies
