• What Is a Food Safety Plan and What Is It Doing on My Table?

    22 September, 2015 W. Lynn Hodges, HACCP Consulting Group, LLC

    Whenever you go out to eat with your family, co-workers, or friends, you may be unaware that many of the restaurants (food service establishments) and retail food stores have some type of food safety plan in place. Most of the chain restaurants have sophisticated food safety systems designed and implemented for their daily operations and as well as many of the larger, more established restaurants and retail food stores. The U.S. Food and Drug Administration encourages these retail food operations to implement food safety systems and use them throughout the everyday activities of the operations.

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  • Secrets of Form Design: Forms Can Be Fantastic

    24 September, 2015 Nye Joell Hardy, Food Safety Technical and Regulatory Writer

    Okay, you’re ready. You have your policy. You have a great plan. You have the SOPs. Now all you need to do is implement it!

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  • What Do You Do? A Short and a Long Answer

    29 September, 2015 Jon Beckstrand, MasterControl CEO

    I was recently asked point-blank: What does MasterControl do? I was being interviewed for a medical device publication’s podcast, so the question was expected. Still, it forced me to mull over the company’s mission and accomplishments in the past 13 years under my leadership.

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  • MFG DAY 2015: U.S. Manufacturing at a Glance

    30 September, 2015 David R. Butcher, Marketing Communications, MasterControl

    In recent years, a swing in public perception has led to widely held misconceptions of United States manufacturing – that modern manufacturing environments are dark, dangerous and antiquated factories designed for low-skilled workers.

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  • Quality Audit: The Direct Route to Continuous Improvement

    6 October, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

    If your organization is GxP-regulated or ISO-certified, you are no stranger to the burdens of audit. The regulations and standards that govern your operations change often, and yet you must somehow manage to understand and comply with them – and be able to clearly demonstrate your compliance – at all times.

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  • Risk Takes Center Stage in ISO 9001: 2015

    8 October, 2015 Lisa Weeks, Marketing Communications, MasterControl

    If you’re unfamiliar with the concept of risk, or your exposure to it has been limited, now is the time to get comfortable with all aspects of risk as it relates to the quality management system. Why? Because the latest edition of the standard makes risk management, which has always been implicit, explicit. In other words, it’s no longer optional; it’s a must.

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  • How Scary are the Device Safety Requirements in IEC 60601-1 Edition 3.1?

    13 October, 2015 Lisa Weeks, Marketing Communications, MasterControl

    Few things are more frightening to an overwhelmed and under-resourced medical device manufacturer than a change to a regulatory standard, particularly if it’s a big one. (Cue creepy music.) Such is the case with IEC 60601-1 Edition 3.1, the internationally recognized standard that addresses the general requirements for medical electrical equipment and devices. Amendment 1, which was introduced in 2012, contains more than 250 changes to the text of the standard, many of which significantly alter the standard’s meaning and/or intent. Scary, right? Even scarier, the FDA will begin enforcing the new requirements as early as August 2016. Yikes!

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  • Personal PDCA and How I Learned It

    15 October, 2015 Mark Reich, Chief Operations Officer, Lean Enterprise Institute

    In 23 years at Toyota, I had many assignments and different bosses, I managed many people, but a constant part of the culture was what I’ve come to call “personal PDCA” – a kind of mentored self-development cycle. When it comes to personal PDCA, my first problem solving experience during my first-ever assignment in Japan stands out for me.

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  • Trust is Not Just Nice, It’s the Key to Your Success

    19 October, 2015 Cindy Fazzi, Staff Writer

    Whether you’re a quality professional responsible for your system implementation or a CEO getting ready to launch a medical device startup, Stephen M.R. Covey believes there’s one thing you need to succeed—trust. “Trust is an economic driver, not merely a social virtue,” he said in his keynote address at the 2015 Masters Summit.

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  • FSMA: Get Inspection-Ready with These Best Practices

    20 October, 2015 Melanie J. Neumann, J.D., M.S. Executive Vice President The Acheson Group

    Although FDA immediately gained increased authority for records access upon the signing of the Food Safety Modernization Act (FSMA) in January 2011, some companies haven’t gotten the memo yet.

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  • 6 Traits You Should Develop to Become an Exceptional Quality Pro

    22 October, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros.

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  • Still Using Paper for Audits? Here’s Why You Need to Automate

    27 October, 2015 Steve Harrison, Product Manager, MasterControl

    A recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries.

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  • 10 Halloween Costumes that Will Inspire Quality Professionals to Communicate Even More Effectively with Their Executives

    28 October, 2015 Marci Crane, Marketing Communications, MasterControl

    Employment pundits say in today’s job market, it’s not enough to have skills and education. Today’s top employees must “dress for success.” What better time is there than the end of October to consider a bit of dress up?

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  • Streamlining CAPA Processes: Manual Systems vs. Automated Solutions

    29 October, 2015 by James Jardine, Marketing Communications, MasterControl

    The real challenge in managing corrective and preventive actions (CAPA) isn’t knowing whether or not you’re making the right decision or the wrong decision. It is understanding if you’re making smarter and better decisions. There are any number of ways a manufacturer can handle a quality event, but what is most crucial is that the organization is in the best possible position to effectively deal with that event.

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  • How Donald Trump and/or Hillary Clinton Would “CAPA the USA” if Elected in 2016

    3 November, 2015 Marci Crane, Marketing Communications, MasterControl

    Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise.

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  • Training Effectiveness – A Quality by Design Approach

    5 November, 2015 Holly DeIaco-Smith, MS, HDS Consulting

    In the role of a consultant, you have the benefit of seeing what works well across your client base and their shared common pain points. Because of this perspective, I’m often invited onto a project to provide guidance on best practices and practical advice on how to avoid the common pain points.

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  • Why Every Business Needs to Make ISO Certification a Priority in 2015/2016

    10 November, 2015 Stuart Patch, Content Writer, Compass Assurance Services; info@compassassurance.com.au

    There are many benefits for organisations gaining certification and for those organisations that are currently certified, ensuring those benefits continue to be realised is very important. Below I look at the benefits of certification and also what are the benefits of keeping abreast of upcoming changes in standards.

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  • 6 Military Skills Highly Valuable to Manufacturers

    11 November, 2015 David R. Butcher, Marketing Communications, MasterControl

    Following years of high unemployment, the hiring outlook for service members transitioning into the civilian labor force is improving. The unemployment rate for veterans from all branches of the military is now just 3.9 percent, compared with 4.5 percent a year ago and a current national unemployment rate for all Americans of 5 percent, according to the U.S. Bureau of Labor Statistics last week.

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  • eTMF Management: Don’t Settle for a One-Trick Pony!

    12 November, 2015 Patricia Santos-Serrao, MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement. With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.

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  • The Future of Medical Device Registries

    17 November, 2015 David R. Dills, Sr. Consultant, Regulatory & Compliance, Devices: NovusLife

    A registry is broadly defined as a collection of information about individuals, usually focused around a specific diagnosis, condition, or intervention. Individuals may provide information about themselves to a registry on a voluntary basis, either directly or through their physicians. A registry can be sponsored by a government agency, nonprofit organization, health care facility, or private company, and over time can provide researchers and other health care delivery stakeholders with first-hand information about patients, both individually and as a group, which can increase our understanding of that condition. This post places key emphasis on medical device registries and why this topic is becoming increasingly important with FDA and our device manufacturers.

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