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 […]
Presented by: Era Sciences As regulatory scrutiny around computerized systems continues to grow, staying inspection-ready is no longer optional. In this webinar, we’ll explore how life sciences teams are enhancing oversight, validation, and audit preparedness across both GxP and GCP environments. You’ll learn why maintaining a reliable, compliant, and up-to-date asset list of computerized systems […]
Taylor DieringerSenior Staff Quality Engineer – Risk Management iRhythm Technologies, Inc. In medical device risk management, the structure of a hazard analysis greatly impacts both product development and post-market surveillance. A clear, intentional structure supports traceability, aligns with ISO 14971:2019, and enables effective risk control. This article explores three common structures for hazard analysis and […]
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 […]
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