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| Redefining Pharmaceutical Process Validation When: March 26, 2009 FDA's new process validation guidance spells out the new rules for process validation. In this live webcast, FDA enforcement chief Joe Famulare talks about the guidance, while Jim Agalloco spells out what it means for manufacturers, specifically for sterile processing; Bikash Chatterjee of Pharmatech outlines how to apply a Six Sigma approach to validation, while NNE-Pharmaplan's Line Lundsberg-Nielsen discusses how to apply new principles to improve a legacy product. » Register Today Thank you to our sponsors: Pharma Traceability in the Real World: The Bottom-Line Benefits In a webcast aired on March 12 by PharmaManufacturing.com, these points were addressed by experts including a participant in the BRIDGE pharma traceability project, part of a broad traceability project that involved generic pharmaceutical manufacturers, packagers, wholesalers, warehouse operations, and hospitals in Europe. The goal of this project was to demonstrate the feasibility of implementing track and trace technology from the drug manufacturing plant to the hospital pharmacy. John Clark, commercial director of the generic drug manufacturer Athlone Laboratories, discussed some of the technical challenges that the project involved, as well as the benefits. Joining him were Henri Barthel, director of partnerships with GS1, colleague Jan Deneker, as well as Aberdeen Group senior analyst Matthew Littlefield, who presented data suggesting that drug manufacturers have been improving key supply chain performance metrics because of their traceability and compliance initiatives. » Click here to watch this webcast Thank you to our sponsors: |
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