• Why Russia Is an Attractive Market for Clinical Trials

    16 August, 2016 MasterControl

    When you think of countries as candidates for clinical trials, which ones come to mind? North America, Great Britain, France?

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  • Leverage the Power of SOPs

    4 August, 2016 Cindy Fazzi, Staff Writer

    Most companies establish standard operating procedures for compliance purposes, but that’s just the start and it doesn’t leverage the power of SOPs, according to Lillian Erickson, MasterControl’s global quality manager, in a recently published article in Fleet Maintenance magazine.

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  • A Warehouse Love Song

    26 July, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Storing stuff doesn’t sound like it should be difficult, but complying with FDA’s detailed regulations for warehousing pharmaceuticals can be. To start, your warehouse has to be clean and pest-free. Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering. Your facility also needs proper drainage, ventilation, adequate space, and work lighting. (Is your warehouse susceptible to flooding? Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?) You also have to make sure your product is not exposed to more heat, cold, humidity, or light than stability testing recommends. (Do you have moisture and temperature sensors throughout? Is the heat tunnel you use for sealing shrink wrap too hot? Do you have backup refrigeration? Have all of these devices been cleaned, serviced, inspected, and calibrated?) And what are your procedures if you find any safety threshold has been exceeded? Are your people adequately trained?

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  • The Proper Role of the FDA in the 21st Century

    21 July, 2016 Dr. Joseph Gulfo, Executive Director, Rothman Institute of Innovation & Entrepreneurship

    The current medical marketplace is vastly different from the marketplace that existed when the basic elements of Food and Drug Administration law were passed. Despite rapidly advancing technology and patients’ increasing desire to try new drugs and devices, the FDA has strayed significantly from the statutorily defined safety and effectiveness standards for drug approvals. The FDA now very often demands proof of clinical utility, including survival and disease outcomes, as a requirement for premarket approval. But hard proof of clinical utility is elusive, even for drugs that are clearly shown to be safe and effective as labeled. Rather than blocking safe and effective drugs on such grounds, we should allow physicians and patients to make outcome-oriented decisions, and rely on the medical marketplace to drive physician adoption of safe and effective drugs that prove to have great clinical utility in real-world settings.

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  • Your Suppliers’ Risk Is Your Risk

    14 July, 2016 By Carrie Mantey

    In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.

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  • What Will Quality Look Like in 20 Years?

    12 July, 2016 Peter J. Holtmann, President and CEO, Exemplar Global

    To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”

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  • What, No Internal Audits?

    21 June, 2016 Dr. Christopher Joseph Devine, President Devine Guidance International

    For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.

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  • Six Steps to Qualifying Suppliers

    16 June, 2016 by Robert Packard, Packard Consulting

    Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

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  • The Dude Abides! 5 Quotes from “The Big Lebowski” that Apply to Quality

    14 June, 2016 Cindy Fazzi, Staff Writer

    “The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.

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  • 2016 Masters Conference in Amsterdam Sheds Inspiring Light on Quality

    7 June, 2016 Beth Pedersen, Marketing Communications, MasterControl

    Quality, regulatory, IT and management professionals across pharmaceutical, medical device, biotech and manufacturing came together for two days of learning and networking last month in the friendly host city of Amsterdam. Now in its sixth year, MasterControl’s annual Masters Conference, held 11-12 May, offered the user community in Europe a chance to rub shoulders with industry experts, exchange knowledge and experiences with others in the same profession, and receive one-on-one consulting from the MasterControl team. From humorous to emotional and everything in between, the wide variety of presentation topics showed just how diverse and impactful the field of quality can be.

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  • Kaizen Means You Care

    2 June, 2016 Dan Markovitz, Markovitz Consulting

    I’m shepherding this company along its lean journey, and we’ve started by asking people to simply fix what bugs them. We’re not making people sit through lots of classes, we’re not doing 5S, we’re not trying to “move the needle” on the business—we’re just trying to get people to see that the way things were yesterday isn’t the way they have to be today. We want people to know that they have the power to make things better and easier for themselves. We often forget that’s the real first step in establishing a culture of kaizen—just knowing that you’re allowed to improve things.

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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  • SOP Revision SWAT-Style

    19 May, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.

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  • Five Reasons Why TMF Training is Important

    17 May, 2016 Sholeh Ehdaivand, President and CEO, LMK Clinical Research Consulting

    Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, U.S. companies spent over $70 billion on corporate training in 2014, an increase of 15% over the previous year. If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees on board, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always inspection ready.

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  • Cleanroom Compliance: How to Address Common Challenges in Document Control

    5 May, 2016 Dave Hunter, Product Management Director, MasterControl

    A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).

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  • Don’t Trip over These 9 Document Control Pitfalls

    26 April, 2016 Dave Hunter, Product Management Director, MasterControl

    Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).

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  • Income Tax Myths and Document Control Systems

    5 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    I’ve been reading Steve Berry’s novel, “The Patriot Threat.” The crux of the book is that the 16th Amendment to the Constitution, the one that requires Americans to pay income tax, may be illegal. The story goes that some of the states may have never ratified the Amendment, and some may have ratified a document that didn’t have the same wording as others. (I won’t spoil the mystery by telling you what transpires.)

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  • ISO 9001:2015 - A Powerful Addition to Your Professional Tool Kit

    29 March, 2016 Greg Peckford Founder, Quality Career Advancement

    There are over one million organizations in over 170 countries registered to ISO 9001. That alone is a pretty impressive statistic claimed by www.iso.org. But what this stat is missing are the countless other companies worldwide that have adopted the ISO 9001 standard as a blueprint for the development and implementation of their quality management systems without becoming formally certified.

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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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  • 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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