• EU Pharmacovigilance Legislation

    12 June, 2013 by Steve Jolley, SJ Pharma Consulting LLC

    The new legislation represents the biggest change to EU pharmacovigilance requirements since the formation of the European Medicines Agency (EMA) and will have a significant impact for regulators and industry.

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  • The 'Supply Chain' Patient is Sick

    21 February, 2012 Hedley Rees, Biotech PharmaFlow

    Hedley Rees looks at the problems with the pharmaceutical supply chain and questions whether they can be resolved.

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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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  • 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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  • Regulatory Submissions: Filling the Critical Gaps in EDM Systems

    11 July, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    It's been said that electronic document management (EDM) systems for the management of submission documents are "a dime a dozen." However not all EDM systems are created equal, at least not when it comes to the management of final submission documents. Many of us are familiar with the standard functionality that most EDM systems provides particularly in the life sciences space such as: document types, taxonomy, version control, lifecycle management, securities, PDF rendering, watermarks, and el

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  • The Rising Costs of Clinical Trials

    31 January, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl

    One of the most costly areas of business for any Pharmaceutical or Biotechnology Company has always been clinical research. Now more than ever the cost of bringing a product to market is staggering and as patents on trademark products expire the hope for recovering costs of research get smaller and smaller.

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  • Risk-Based Approach to Monitoring: The Value of Data in Clinical Studies

    3 May, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    In August 2011 the Food and Drug Administration (FDA) released a guidance entitled "Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring," which highlights a new approach to clinical site monitoring different from that of years ago. In this most recent guidance, the FDA openly states that "Many sponsors have understood that FDA expects sponsors to conduct frequent on-site monitoring and 100% data verification for all trials," clarifying that this is not always the best approach or the most productive use of time.

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  • Avoiding Human Error in Design

    14 August, 2013 BW (Ben) Marguglio, President, BW Marguglio, LLC

    Any enterprise that is engaged in activities with the potential for public and employee harm should be encouraged, if not required to develop and implement an integrated risk management, safety management, quality management and environmental management system for the prevention of events with intolerable effects. Such a management system would establish various techniques by which to analyze the safety and quality of the designs of hardware and processes.

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  • How to 'Sell' Quality

    30 October, 2012 Deborah Mackin, Performance Strategy Consultant, New Directions Consulting

    ASQ CEO Paul Borawski asked us to comment on the question, "How do you 'sell' quality to decision makers?" While everyone theoretically believes in the importance of quality, there are times when the demands of the customer cause the focus to shift to speed and cost. Probably many quality heads of departments have been asked to compromise quality requirements at some point to get product out the door.

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  • Peeling the Onion to Improve Human Reliability

    11 December, 2012 Stacy Berkshire, Senior Director of Global Quality Programs, Perrigo Company

    Humans will make mistakes. Industries have been focusing on strategies to reduce or even eliminate human error in efforts to keep consumers and employees safe. Pharmaceutical companies are responsible for ensuring that their products are safe, labeled correctly, have the correct strength, are pure, and are produced with good quality. In the pharmaceutical industry when deviations are identified as a result of an error, organizations follow a deviation investigation process to understand the root cause and put in a corrective action to fix the problem.

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  • Quality Professionals: How to Increase Your Job Security

    31 January, 2013 Cindy Fazzi, Staff Writer

    The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?

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  • 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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  • Avoiding Remediation with a Good QMS

    15 May, 2013 Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

    Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic document management system (EDMS) approach that is typically post mortem. This is risky business at two critical levels. First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes. Secondly, the response will need to have a litany of justif

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  • Developing a QMS: Should You Buy or Build?

    11 December, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

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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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  • When Good Teams Go Wrong

    17 July, 2012 by Ruth Dubinsky, MS, President, Clarity Consulting

    How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members?

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