• 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • Implementing a Systems Approach to Parmaceutical Quality Systems

    22 April, 2012 Christine Park, Quality Architech, Christine Park & Associates

    In 2002, the Food and Drug Administration (FDA) announced an initiative to integrate quality systems and risk management approaches into existing regulations for pharmaceutical manufacturing. While the FDA hasn't changed the 21 Code of Federal Regulations (CFR) Parts 210 and/or 211 regulations, they have published industry guidance, Quality Systems Approach to Pharmaceutical CGMP Regulations.

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  • Outsourcing Trends for 2012

    22 March, 2012 by Kate Hammeke

    With the goal of optimizing collaborations in the drug development industry, Nice Insight (http://niceinsight.com/) developed a quarterly survey to measure customer awareness and customer perception across 300+ contract research and manufacturers. Nice Insight's Q4 Pharmaceutical and Biotechnology Outsourcing Survey generated responses from 2,619 outsourcing-facing executives from big pharma (29%), specialty pharma (17%), emerging/niche/start-up pharma (22%), biotechnology (25%), and emerging biotechnology (7%). In addition to creating a research tool that aids sponsors in the outsourcing partner selection process and enabling CROs and CMOs to understand their position within the industry, Nice Insight also garners broad industry trends from its survey data.

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  • The Odd Couple - Quality vs. Research

    29 February, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solu

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  • Introduction to High Risk Software Automated Testing

    24 April, 2013 Brett Castano, Clinical Operations Manager, RealityCorp

    In today's world, high risk software applications are managing a majority of clinical trial data collected in the field. In the early 2000s, the clinical trial industry saw a switch from managing the data collection process through manual means to doctors utilizing secure software applications that allow the doctor to enter the data electronically through the use of a computer or mobile device. MasterControl itself is an example of a high risk software system that is utilized within the clinica

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  • Highlights of the 2012 Revised EU Pharmacovigialnce Regulations

    29 January, 2013 Sidney N. Kahn, Pharmacovigilance & Risk Management, Inc.

    In December 2010, the European Commission (EC) published legislation for implementation in July 2012 that made the most sweeping changes to European pharmacovigilance since 1995. Directive 2001/83/EC, covering non-centrally approved products, was amended by 2010/84/EU, and Regulation EC/726/2004, governing centrally approved products and European Medicines Agency activities, was amended by 1235/2010. The goals of the new requirements are to:

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  • Drug Accountability in Clinical Trials

    3 May, 2012 Dr. Robbie Wong, Pharm.D., Clinical Development Consultant and Affiliate Assistant Professor, Dept. of BioEngineering, University of Washington

    It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.

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  • Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore

    22 March, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Note: The views expressed in this article are those of the author and do not necessarily represent those of her employer, GxP Lifeline, its editor or MasterControl, Inc.

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