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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.

    Posted in Featured, QbD News0 Comments

    Tech Transfer in the Age of QbD

    Tech Transfer in the Age of QbD

      Arvindh Balakrishnan, Former VP of Life Sciences, Oracle and Russ Somma, President, SommaTech LLC discuss the components of characteristics of modern and effective technology transfer.  New approaches and more comprehensive outlooks are vital to product/process understanding and speeding time to market.

      Listen to 18:06 minute podcast

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      QbD For Powder Characterization:  From Lab to Plant

      QbD For Powder Characterization: From Lab to Plant

        Some things are worth sharing again.  In a 2009 interview with Tim Freeman at Freeman Technologies Tim discusses the fact that powder behavior decisions made during formulation – which parameters to measure, for example – become more critical later on and are critical factors for effective QbD.

        Listen to 4:05 min podcast

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        No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion

        No More Tire Kicking: Chris Amstutz Shares Views on PAT’s Expansion

          At the recent Interphex 2012 show in New York City, Agnes Shanley caught up with Chris Amstutz, Director of Life Science Industry Consulting at Emerson Process Management. In the video below, Amstutz provides a brief look at the recent progression of PAT and QbD in the drug industry.

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          Rees’ Modest Proposal: Fully Integrated Research & Development

          Rees’ Modest Proposal: Fully Integrated Research & Development

            In a just-posted audio interview with Gareth Macdonald of inPharmatechnologist.com, Hedley Rees, managing consultant at Biotech PharmaFlow, describes his vision of a two-stage drug development model, one that includes a design stage (fully integrating research and development units) and manufacture stage.

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            America’s Top Modelers: Accelerating Pharma Process Development

            America’s Top Modelers: Accelerating Pharma Process Development

              By Paul Thomas, Senior Editor

              This week in Rosemont, Illinois, DynoChem software (from Ireland’s Scale-Up Systems) hosted its annual North American user group meeting. User groups are wonderful opportunities to learn what’s really happening behind closed doors at leading companies. At the DynoChem meeting, chemical engineers and modeling experts from Eli Lilly, Abbott, Pfizer, Merck, GSK, Amgen, and other major manufacturers shared details of their current advanced process modeling.

              Posted in Audio & Video, Expert Insights0 Comments

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