Archive | QbD News

An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group

An Invitation from PMcG Consulting to Attend the 5th Evening QbD Discussion Group

    This discussion group activity provides the opportunity to get up to speed with the current status and future trends of analytical method qualification.

    Guest speaker will be:

    Dr. Phil Nethercote, Glaxo SmithKline Inc.

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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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      ISPE Conference to Benchmark and Advance Quality by Design in the Biopharmaceutical Industry

      ISPE Conference to Benchmark and Advance Quality by Design in the Biopharmaceutical Industry

        ISPE  it will hold its first-ever conference focused on benchmarking and advancing the development of Quality by Design in the biopharmaceutical industry. The two-day event, taking place 10 – 11 April 2013 in San Francisco, Calif. USA, will feature workshops and discussions on the industry’s progress since the introduction of A-Mab and steps for further adoption of QbD principles. The conference is endorsed by CASSS, a not-for-profit 501(c)(6) professional scientific society made up of over 4,000 industry, academic and public sector professionals.

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        Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

        Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

          Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility – focusing more heavily on identifying and monitoring critical process steps than on reviewing batch records.

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          Nominations for AIChE QbD Awards: 2013

          Nominations for AIChE QbD Awards: 2013

            AIChE is now asking for nominations for their 2013 QbD awards.  There are three awards including:

            • Outstanding Contribution to QbD for Drug Substance, sponsored by Scale-up Systems
            • Outstanding Contribution to QbD for Drug Product, sponsored by Pfizer
            • Excellence In Integrated QbD Practice, sponsored by Merck

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            20% Conference Savings for PharmaQbD.com Members to Attend IBC’s Biopharmaceutical Development & Production Week

            20% Conference Savings for PharmaQbD.com Members to Attend IBC’s Biopharmaceutical Development & Production Week

              Members of PharmaQbD.com can save 20%* when you mention savings code BDP13PMSM during registration.

              IBC’s Biopharmaceutical Development & Production Week provides updates on current and emerging Methods to improve your bioproduction capabilities and delivers strategies to help you overcome the challenges and accelerate production of the biopharma industry’s most exciting new Molecules.

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