• Quantifying Quality for GxP Compliance

    30 October, 2012 Emma Barsky and Len Grunbaum, Regulatory Compliance and Operational Consultants

    GxP professionals understand the need for quality and quality systems and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insights on how to quantify quality for the development, manufacture, and distribution of health products such as drugs, medical devices, and biologics.

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  • MasterControl Revs Operational Excellence Using Six Sigma

    24 April, 2013 Craig Gygi, Executive Vice President Operations, MasterControl, Inc.

    The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

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  • Top 10 World Quality Month

    8 October, 2013 MasterControl

    Did you know that November is World Quality Month?  You still have a few days left to create your own list of top ten actions you’ll take to improve the quality of your work.  Here are a few suggestions:

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  • Using History to Predict the Future of Quality

    10 July, 2013 Tim Donaldson, President, Donaldson Group, Inc.

    Predicting the future is fool’s play---think Edsel, Nostradamus, even Chicken Little. But if you or your organization is wrestling with what direction to take your quality programs and your entire organization, perhaps a brief look at history will aid in developing your future strategies and culture of quality.

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  • Quality Misconceptions

    4 January, 2011 Jennifer Stepniowski, Special Project Manager, Pro QC International

    For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.

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  • SPC vs SQC: The Strategic Difference

    1 May, 2013 Jason Orloff, Statistical & Engineering Consultant, Pharmstat

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • Biotechnology Article

    28 May, 2015 MasterControl

    The MasterControl quality management system is a flexible system since it can be constructed from a variety of individual quality control/quality assurance solutions.

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  • New Draft Guidance on Quality Agreements: No Passing the Buck on CGMPs

    10 August, 2013 Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas,Alston & Bird LLP

    Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with

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  • Avoiding the CAPA Calamity

    9 February, 2017 Ken Peterson, Director Quality Services, MasterControl, Inc.

    Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all tha

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