• 6 Ways Quality Managers Can Build a Culture of Quality

    12 January, 2016 Beth Pedersen, Marketing Communications Specialist, MasterControl

    If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?

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  • Do You Really Want to Be An Executive In An FDA-Regulated Company?

    14 January, 2016 James R. Phelps, Hyman Phelps & McNamara, P.C

    Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow. Appropriate to the forum, he focused on the industries regulated by FDA. The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge.

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  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part I

    19 January, 2016 Mark Leimbeck, Program Manager, UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from Basic Safety (only) to include Essential Performance; and second, introduction of a requirement for assessment of the Risk Management process applied by manufacturers in developing their medical devices.

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  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

    21 January, 2016 Mark Leimbeck, Program Manager UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from basic safety (only) to include essential performance; and second, introduction of a requirement for assessment of the risk management process applied by manufacturers in developing their medical devices.

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  • How to Respond to FDA Inspection Observations, Including Those You Dispute

    26 January, 2016 Martin Browning, President, EduQuest, Inc.: FDA expert investigator and rule-maker for 22 years

    Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

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  • One Q & a Lotta A’s about SOPs for Research Sites

    2 February, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    “What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”

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  • CLIA vs QSR (What You Don’t Know Can Hurt You)

    4 February, 2016 Paula Gray, Navigant & Sharon Kvistad, Navigant

    Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use. For all laboratory testing, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), in 1988, which established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.

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  • FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

    9 February, 2016 Jason C. Gavejian, CIPP, Principal, Jackson Lewis P.C.

    Last week (January 22, 2016), the U.S. Food and Drug Administration (FDA) issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance, which details the agency’s recommendations for monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices after they have entered the market, is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats.

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  • When Is A CRO Not A CRO? (And why does that make enforcement hard?)

    11 February, 2016 amie Colgin, Colgin Consulting

    Investigator site personnel recorded observations about clinical trial subjects in paper medical charts. Lab work was performed and interpreted at a local lab; X-rays and ECGs were taken and interpreted locally; and results were sent back to the investigator.

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  • Steak, Peas, and Doughnut Holes

    16 February, 2016 Curt Porritt, SVP Marketing, MasterControl

    In a recent Q&A with Harvard Business Review, Sir David Brailsford, an MBA and former head of British Cycling, highlighted a cycling team that used a continuous improvement process to eventually find great success. Brailsford, who has overseen teams that have won more than a dozen Olympic gold medals and three Tour de France races, explained to HBR how his team focused on making small improvements in various aspects of cycling. The hope was that all of these small improvements would add up to a significant overall improvement in the team’s racing ability.

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  • The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

    18 February, 2016 Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W., Food and Drug Administration

    Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

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  • The Past, Present and Future of CAPA

    23 February, 2016 James Jardine, Marketing Communications Specialist, MasterControl

    Every day, companies in regulatory environments are amplifying their efforts to avoid the seemingly inescapable consequence of an egregiously oversaturated corrective and preventive action program, or, as it’s commonly come to be known, “Death by CAPA”. A recent MedTech Intelligence article by CAPA guru Ken Peterson speaks to the evolution of CAPA, discusses the refinement of effective CAPA programs and hints at what is on the CAPA horizon in the future.

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  • Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness

    25 February, 2016 James Jardine, Marketing Communications, MasterControl Inc.

    If a document control system exists to improve your organization’s productivity and help maintain a continual state of audit readiness, what rudimentary features does it absolutely need to have? The components that are deemed essential may vary slightly from one organization to the next based on individual business requirements, but the following checklist covers the minimum functionality that should be expected from a categorically complete document control software solution.

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  • Quality by Design Part 1: You Can't Design Something You Don't Understand

    1 March, 2016 Beth Pedersen, Marketing Communications, MasterControl

    Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.

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  • ISO 13485:2016 What are the Changes About?

    3 March, 2016 Linda Chatwin, Esq, RAC Manager Medical Regulatory Advisory Services, North America UL LLC

    ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.

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  • The #1 Cause of Medical Device Recalls—and How to Avoid It

    8 March, 2016 Lisa Weeks, MasterControl Communications

    Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

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  • How to Explain Your Quality Job to Young Kids in 4 Steps

    10 March, 2016 Lillian Erickson, Global Quality Manager, MasterControl Inc.

    When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

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  • Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

    11 March, 2016 Robyn Barnes, Marketing Communications, MasterControl

    You may be familiar with what a quality management system (QMS) is, but do you know how to use one at a cross-enterprise level?

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  • Why We Trek to Trade Shows

    14 March, 2016 Jill Bumgardner, Global Events Manager, MasterControl

    Most people generally support the notion that trade shows are still relevant, but sometimes a little pep talk is in order.

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  • Study Sites: Too Many Vendors, Too Little Time

    15 March, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.

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