• Five Tricks and One Philosophy for ISO 9001:2015 Transition

    27 March, 2018 by Colin Gray, Management System Consultant, Cavendish Scott

    Transition to the new version of ISO 9001:2015 is upon us. Many have put it off for a whole host of reasons, and we are now at a point where we all need to act. Differing opinions exist about how easy or how hard the changes will be, but many factors determine that degree of difficulty.

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  • Creating a Lean Culture of Continuous Improvement

    22 March, 2018 by Jared Evans, Professional Instructor and Lean Process Coach, MasterControl

    When working on my bachelor’s degree, I had a memorable experience in a creativity and problem-solving course. In order to calm the growling of our starving student stomachs, the professor said he would reward us with a treat when we turned in our completed homework assignment at the next class period.

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  • Poll Suggests Automation Could Solve 85% of Your Document Control Issues

    20 March, 2018 by Mike Rigert, Staff Writer, MasterControl

    The sophistication and value-added benefits of automated, integrated document control management tools available to manufacturers in the life sciences has come a long way since software solutions were introduced in the 1980s on 5 1/4-inch floppy disks.

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  • Top 10 Takeaways from MD&M West 2018

    15 March, 2018 by David Jensen, Staff Writer, MasterControl

    I recently attended the 2018 MD&M West conference, Feb. 5 – 7, in Anaheim, California. The three-day event pulled together the medical device industry’s top engineering, design and regulatory compliance experts. This year’s conference covered the most timely and pressing topics, including technology, cybersecurity, design control, digital health and regulatory updates.

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  • Here We Go Again With the Medical Device Excise Tax

    13 March, 2018 by Cindy Fazzi, Staff Writer, MasterControl

    When the medical device excise tax was suspended recently, the industry was left with a sense of déjà vu. Between January 2013 and January 2018, the tax was implemented once and frozen twice. How long will this touch-and-go situation continue?

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  • Biosimilars: A Safe and Effective Option for Patients

    8 March, 2018 by Christine Simmon, Executive Director of the Biosimilars Council, a division of the Association for Accessible Medicines

    It is a difficult irony that even as medical breakthroughs and new life-saving and life-extending treatments bring hope to patients and families across the country, it also is getting harder for many to afford these critical medicines. The rapidly rising cost of brand-name biologic medicines, which comprise the vast majority of new therapies in the pipeline, mean they are often inaccessible for America’s patients.

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  • Death by Risk-Based Approach: The Practical Guide to the ISO 13485:2016 Practical Guide, Part 3

    8 March, 2018 by Michelle Lott, Principal and Founder, Lean RAQA Systems, LLC

    This is the third post in the series, “The Practical Guide to the ISO 13485:2016 Practical Guide” for medical devices. This post explores examples and application provided within Practical Guide for the implementation of a “risk-based approach.”

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  • What Improv Comedy Can Teach Us About Communication in Clinical Trials

    1 March, 2018 by Beth Harper, President, Clinical Performance Partners

    A look at how some of the insights behind improv comedy training can help clinical trial teams develop and improve communication and problem-solving skills. It's no laughing matter.

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  • What, No Installation Records?

    27 February, 2018 by Christopher Joseph Devine, Ph.D., President, Devine Guidance International

    Christopher J. Devine delves into the topic of medical device installation recordkeeping, and why proper documentation of this process is essential to successfully installing medtech and avoiding warning letters and other mishaps.

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  • February Tip: Managing Updates to Regulatory Documentation

    22 February, 2018 by Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.

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  • Trend Analysis: A Method for Focusing Resources

    20 February, 2018 by Mark Durivage, American Society of Quality (ASQ) Fellow and Managing Principal Consultant, Quality Systems Compliance

    Probably one of the most significant concerns for anyone responsible for implementing, deploying and maintaining a quality management system is the prioritization of resources. Trend analysis is one technique that can help determine if something has changed with a process (quality, production, or service). Trend analysis can be used to monitor a process, especially non-manufacturing processes such as complaints, nonconformances and deviations to aid in the decision for escalation for corrective and preventive action (CAPA).

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  • New European Med Device Regulation: 2020 Looms Large for Medtech Firms

    15 February, 2018 by Cindy Fazzi, Staff Writer, MasterControl

    In 2020, the United States will hold a presidential election. Tokyo will host the Summer Olympics. For the medtech industry, the European Union’s Medical Device Regulation (MDR) will take effect. Politicians and athletes have been gearing up for 2020 and so should medical device firms.

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  • 3 Valuable Takeaways from the 2018 TMF U.S. Summit

    14 February, 2018 by Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Clinical professionals from around the U.S. gathered Jan. 16-18 at the TMF U.S. Summit 2018 in Orlando, Fla., to discuss current clinical study trends and some of the pressing issues relating to trial master file (TMF) management. Three underlying themes were prevalent throughout the 7th annual event.

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  • Cybersecurity in a Mobile World

    13 February, 2018 by David Jensen, Staff Writer, MasterControl

    Mobile device technology appears to be taking off. Lately, it seems there are more non-phone-call uses for mobile devices than there are lightbulb jokes. The healthcare industry is becoming particularly mobile device heavy. However, in terms of cybersecurity, mobile medical device technology is causing headaches for healthcare organizations.

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  • February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    9 February, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

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  • Are Clinical Research Sites a Dying Paradigm?

    6 February, 2018 by Craig Morgan, Head of Marketing, goBalto

    A recent analysis by the Manhattan Institute determined that Phase III clinical trials account for 90% or more of the cost of developing an approved drug from laboratory to pharmacy. [1] Given that reliable estimates put the cost of developing, and gaining marketing approval for a new drug, at well over a billion dollars,[2] it’s clear that human trials are pivotal to the pharmaceutical industry scrambling to find ways to reduce costs and speed timelines, while maintaining the quality and efficacy of the research.

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  • What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    1 February, 2018 by Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl

    It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

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  • January Tip: Strategies for New Regulatory Managers

    30 January, 2018 by Patricia Santos-Serrao

    A good place to start is to identify the key stakeholders and decision makers in each department. This exercise will show you how close what is on paper is aligned to what is done in practice. Finding out “who is who” in each department will come with an explanation of their activities… pay attention to the overall scheme and coordination that takes and the various approaches, tactics, and means each department uses to accomplish their tasks. You will need this understanding to be effective as a regulatory leader.

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  • Data Integrity: A Return to Basics

    25 January, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    Since the U.K.’s Medical and Healthcare product Regulatory Agency (MHRA) (1) and the U.S.’s Food and Drug Administration (FDA) (2), published on this subject in 2015 and 2016, respectively, data integrity continues to gain importance as an issue. Some workshop participants wondered if this is simply a new trending topic that will quickly fade. I firmly believe that it is not.

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  • January Tip: How to Choose and Use External Consultants

    23 January, 2018 by Jake Walton, Quality Manager

    External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.

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