• American Laboratories Begins Phase II of MasterControl

    12 November, 2014 MasterControl

    American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.  

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  • MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs

    13 November, 2014 Cindy Fazzi, Editor, MasterControl Insider

    The U.S. Food and Drug Administration (FDA) has been protecting American consumers for over 100 years. In the face of increasing global interdependence, the FDA’s responsibility has expanded by necessity; it works with its counterparts throughout the world to help ensure product safety and quality.

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  • Recognition is a Good Thing

    18 November, 2014 Robyn Barnes, PR Specialist, MasterControl

    It’s always nice to know when you are doing well, especially when you’re recognized within your own industry.

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  • It's Not Just You: FDA Regulatory Requirements Really Are Increasing

    20 November, 2014 Alexander Gaffney, RAC

    The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.

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  • Mind The Gap: Are Training Gaps Preventing You From Closing The Quality Loop?

    25 November, 2014 Stephanie Jones, Senior Professional Services Consultant, MasterControl

    If you follow GxP Lifeline regularly, you’ll notice that we’ve been talking a lot about the concept of closed-loop quality recently, and here’s why. In the face of an increasingly competitive business environment, manufacturers are discovering that traditional approaches to quality management are no longer working (and haven’t been for quite a while). Treating compliance as a series of data or process silos that vary with department or product lifecycle stage simply won’t cut it anymore. A closed-loop approach is what’s needed today because it provides a more holistic view of product and process quality throughout the value chain as well as a considerable competitive advantage.

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  • A Bipartisan Success at Getting Drugs to the Pharmacy Faster (and Cheaper)

    2 December, 2014 Suzanne Junod, U.S. Food and Drug Administration

    Most medications used to be expensive – much more expensive than they are today. As recently as the early 1980s, most important drugs on the market were brand names under patent protection. Generics were uncommon; the cost of developing and marketing them in competition with the big brands was too high. Without change, the relative ease with which most of us get and use prescription drugs today might have been quite different.

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  • Two Keys to Prosperous B2B Customer Partnerships

    4 December, 2014 James Jardine, Marketing Communications

    It may be a trite and simplistic aphorism, but it’s one that’s hard to live by in a competitive business world. Yet the companies that stay true to it are always the most successful. That’s because a company that provides products and services to other businesses is only as valuable as the value it supplies. Think of it this way: ‘why’ a company does what it does is even more important than ‘how’ the company does it or ‘what’ it is actually doing.

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  • How to Address the Top 3 Supplier Management Issues

    11 December, 2014 Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency—in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

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  • FDA New Guidance on Informed Consent: Updates to Required Elements

    16 December, 2014 Paul Cobb, Clinical Research Associate, IMARC Inc.

    In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process: 

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  • Basics: Documenting a Real QMS

    18 December, 2014 T. Dan Nelson, Consultant

    Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

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  • Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

    23 December, 2014 Cheryl Wagoner, Principal Consultant/Owner, Wagoner Consulting LLC

    As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard.  The current FDA guidance regarding biological evaluation of medical devices,

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  • Have a Quality Holiday Season

    24 December, 2014 MasterControl

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  • Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success

    30 December, 2014 Cindy Fazzi, Editor, MasterControl Insider

    Stedman Graham, CEO of S. Graham and Associates and a best-selling author of motivational books, shared the secret to his success. No, it’s not Oprah, though he’s widely known for his long-time relationship with one of the world’s most famous media personalities. 

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  • Enjoy a Quality New Year!

    1 January, 2015 MasterControl

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  • Risk Management: A Primer for Lean Quality Assurance

    6 January, 2015 Gina Guido-Redden Co-Founder, Coda Corp USA

    In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

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  • Enter The Digital Risk Officer

    8 January, 2015 Nicola (Nick) Sanna President, Digital Risk Management Institute

    In the brave new world of digital risk management, a CISO would report up to a DRO who manages risk from a business perspective and works with peers in business operations, compliance and IT security.

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  • What Does Risk-Based Monitoring Mean for QA Auditing?

    13 January, 2015 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

    By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

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  • Setting an Organization's Risk Management Context

    15 January, 2015 Rod Farrar, Director, Paladin Risk Management Services

    There is considerable confusion in the risk world in relation to terms such as risk appetite, risk tolerance, risk acceptance, risk threshold and risk attitude (just to name a few).  These are defined differently by organisations and there is no guidance in ISO 31000 that clarifies this, so the confusion becomes a distraction.

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  • Five Steps to Building Process Efficiency with Your Supplier

    20 January, 2015 Stephen Gerald O’Neil, Consultant

    In order to achieve success with your outsourced manufactured medical devices, there must be cohesiveness between the manufacturer (Supplier) and the product developer (Customer). I’ve exemplified this role as that of the supply chain liaison consultant, involved directly with the development of the manufacturing processes, while in step with the roll-out of the product design intent. This article will discuss the five steps required to accomplish all of this while defining the role of the consultant. The consultant provides the tools and leadership to maximize the value of the supplier in their partnership with the customer.

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  • Getting Ready for ISO 13485:201X (Part 1)

    22 January, 2015 Lisa Weeks, Marketing Communications

    As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see.

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