Case study: Amylin's Improved Aseptic Gowning and Monitoring Program Using MODA™ Solution
Paper-based processes still burden most QC micro programs with paper scheduling, lab marker labeling of sample media, manual reconciliation, paper log book entry, and manual notification on deviations. These steps are labor-intensive, time consuming, and yield duplication of tasks and high error rates. Amylin, a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines, has successfully implemented MODA™—a paperless QC Micro solution by Lonza. As a result, Amylin is achieving their goal to automate their QC processes and regulatory compliance at their manufacturing facility.
Dominick Villani, Manager of QC Microbiology, Amylin Pharmaceuticals
• Industry best practices, strategies, and regulatory guidelines
• Definitions of qualification, re-qualification and routine monitoring
• Use of automation and the MODA™ solution to meet requirements
• Tracking, trending, and report generation compliance using MODA™ solution
Click here to download the webinar PDF presentation and video recording (From June 7, 2011)
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