Tag Archive | "PDA"

Coming in May: A-Vax


The much-anticipated A-Vax QbD case study is due out in May, courtesy of the CMC Vaccine Working Group consortium. If you’d like to be one of the first to see it, and discuss it, head to Bethesda on May 14. A-Vax is being billed as a “landmark” document, in the vein of the A-Mab and the ACE case studies before it. More information and registration details for the “Applying QbD Principles in Vaccine Development” workshop can be found on the PDA website.

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QbD for Pharma Packaging Components: A Solution Provider Gets More Science-Based


By Paul Thomas, Senior Editor

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LinkedIn LookIn: Eavesdropping on QbD Conversations


Every so often we like to eavesdrop on some of the better QbD- and Quality-related conversations happening on LinkedIn pharma groups. Here are November’s hot discussion threads. (The group name is in parentheses. Not a member? Ask the group manager for an invite!)

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Knowledge Management: 8 Success Factors


By Paul Thomas, Senior Editor

At the PDA Annual Meeting in San Antonio today, Thomas Peither, principal consultant with Halfmann Goetsch Peither AG, discussed concepts that are guiding work being done by one of PDA’s Paradigm Change in Manufacturing Organization (PCMO) task forces—dedicated to: “Capture Knowledge Management during Commercial Manufacturing.” The task force has been working for a year and a half now, with the goal of publishing its own technical documents soon.

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An Update on PDA’s PCMO: Getting Technical


By Paul Thomas, Senior Editor

At the PDA Annual Meeting in San Antonio today, Roche’s Stephan Roenninger, PhD, chair of PDA’s Paradigm Change in Manufacturing Operations (PCMO) initiative, provided an update on where PCMO stands roughly a year and a half after its inception.

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Tracking the Rapidly Evolving World of Rapid Micro Methods


FDA’s PAT guidance states: “It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.”

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