• Evaluating the Effectiveness of a Corporate Compliance Program: A Holistic Approach

    21 October, 2014 Brian A. Dahl Dahl, Compliance Consulting

    Now more than ever, pharmaceutical companies must not only have an effective corporate compliance program in place, but senior management and boards of directors at these companies must ensure that they evaluate the effectiveness of those programs. The best reason to evaluate the effectiveness of your compliance program is so that you know whether or not the program is managing the particular risks facing your company. If you are responsible for protecting your company from risk, shouldn’t you want to know that your compliance program is working?

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  • From Good to Great – The One Skill Great CRAs Possess

    23 October, 2014 Holly Deiaco-Smith, MS

    Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

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  • What Is Driving More Organizations to Plan an EQMS Adoption?

    28 October, 2014 David R. Butcher, Marketing Communications, MasterControl

    In response to increased pressure to simultaneously meet compliance, mitigate risks and improve cost savings, a growing number of organizations are taking steps to transform their quality management by adopting enterprise quality management software (EQMS). Research indicates that approximately 40 percent of companies are currently planning to implement an EQMS solution. What are the key drivers behind the rising number of companies moving toward EQMS adoption?

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  • How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market

    30 October, 2014 Lisa Weeks, Communications Specialist, MasterControl

    Having a great product does not guarantee success. The road from concept initiation to commercial release is a long and arduous one. Success depends upon not only understanding the new product development process, but also the FDA submission process, and the complex interplay between the two. Many companies underestimate the value of a carefully thought-out submission strategy. They focus solely on product development and treat the approval process as an afterthought. Others are so eager to get their product to market, they rush the design and testing processes and end up with a product that’s dogged by costly delays or, worse, unmarketable.

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  • Surviving ISO 9001: 2015

    4 November, 2014 Christopher Paris, VP Operations, Oxebridge Quality Resources

    The next revision of ISO 9001 is due in 2015, and the standard is being anticipated with more controversy than any previous edition. The document, now in its Draft International Standard (DIS) stage, is nearly a done deal, with very few changes likely before it progresses to its final release.

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  • MasterControl Says “Go Live” to Localized Websites

    6 November, 2014 Jason Clegg, Director of Marketing, MasterControl

    At its core, website translation is a process that allows everyone across the globe to access the same opportunities and/or products in their own languages. This is especially important to companies like MasterControl that are expanding in to international markets.

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  • MHRA Opens One Stop Shop for Regenerative Medicine Information

    11 November, 2014 Robyn Barnes, PR Specialist, MasterControl

    A new ‘one stop shop’ that will provide regulatory advice for those working in the life sciences industry on regenerative medicines has been launched, according to the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA).  MHRA is an executive agency of the Department of Health in the United Kingdom responsible for ensuring that medicines and medical devices work and are acceptably safe.

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  • 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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