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Teva Changing Their Approaches With Quality by Design

Teva Changing Their Approaches With Quality by Design

    Teva committed to QbD methodology implementation in late 2010. Inna Ben-Anat, QbD Strategy Leader, leads the ‎implementation at Teva’s global generic R&D from Sellersville, Pennsylvania. Inna, together with Yatindra Joshi, VP Global GR&D for the US market, and Uri Hillel, Head of Quality, Global R&D, implemented the global QbD training program. This program supports R&D teams in developing QbD strategies and optimizing formulations and processes using statistical tools; assisting in the development of robust product specifications.

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    More PAT Video from Pfizer UK: Using NIR to Monitor Tray Drying

    More PAT Video from Pfizer UK: Using NIR to Monitor Tray Drying

      Ian Clegg and his Global R&D team in Sandwich U.K. have made available another video illustrating their PAT work. (Previous installments shared applications for Mid-IR and NMR spectroscopy.) The latest video shows how Near Infrared (NIR) spectroscopy can be used to monitor gases leaving a tray dryer, which can facilitate the timing of lab samples as well as cycle time reduction. Appreciation again to the folks in Sandwich.

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      Allergan CEO:  Reform Will Drive Manufacturing, R&D Efficiency

      Allergan CEO: Reform Will Drive Manufacturing, R&D Efficiency

        In this videotaped interview, Allergan’s CEO David Pyott, discusses the impact of healthcare reform on the industry.  Efficiency, in manufacturing, R&D and other efforts, will be key, he says.  Will the need for efficiency spur interest, and corporate investment, in QbD and PAT?

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        Video: What Do Pharmaceutical Manufacturers Really Need to Know about ICH Q8R?

        Video: What Do Pharmaceutical Manufacturers Really Need to Know about ICH Q8R?

          Insights from our QbD Chat video series, with Bikash Chatterjee of Pharmatech Associates.

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          Video: James Blackwell on QbD for Biopharmaceuticals

            At Bioprocess International’s 2009 conference, James Blackwell talked about QbD for smaller companies, and the importance of starting with the risk-management piece. Studying documented case studies from other industries can help professionals make a strong business case for QbD to senior management, he says.

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