Showing items tagged as Biotechnical

  • Airplane Preflight Check Exemplifies Quality in Med Device Design

    10 October, 2018 by David Jensen, Staff Writer, MasterControl

    Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.

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  • What Biotech Startups Need to Do to Slay the Competition

    21 June, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • New Report Highlights Need to Reduce R&D Cost

    19 February, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Most pharmaceutical and biotechnology companies already feel the pressure to reduce their R&D costs. A recent report showing a decline in the ROI for R&D among some of the world's biggest companies is not going to ease the pressure.

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  • Address Root Cause of R&D

    12 June, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Pharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies. Most companies focus their efforts on "enhanced clinical trial designs" that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development.

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  • Reducing Human Error on the Manufacturing Floor

    15 June, 2010 MasterControl

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin.

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  • Biosimilars Establishing Themselves in Europe

    12 December, 2013 Peter Calcott, President, Calcott Consulting LLC.

    From the introduction of the Guidelines for Biosimilars in the EU in 2004, Europe has been pressing hard for the introduction of these money-saving options into the marketplace.  The initial guidelines of 2004 were followed very rapidly with further guidances on comparability (2005), preclinical and clinical requirements (2005), recognition of the changing landscape (2010) and in 2011, further recommendations for studies and statement of the recognition of the issues surrounding lice

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  • What’s in Your Training Toolkit?

    29 January, 2014 David Hofstetter, Manager, Learning and Development at New England Organ Bank

    Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request? 

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  • Where Are You in Your Quality Management Maturity?

    31 January, 2014 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.

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