• 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 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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  • 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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  • 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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  • The Right EQMS for the Homeopathy Crackdown

    18 January, 2018 by Sarah Beale, Staff Writer

    For nutraceutical companies, recent headlines promising an FDA crackdown on homeopathic products were probably a bit unsettling. Traditionally the FDA hasn't been involved with homeopathy, but this new guidance means that companies will have to become compliant with these six risk-based categories.

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  • Risk-Based Approach as Clear as Mud

    16 January, 2018 by Michelle Lott, Principal and Founder, Lean RAQA Systems

    This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.

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  • Ensuring Quality In Medical Device Trials

    11 January, 2018 by Mary Lewis, Senior Clinical Research Specialist, IMARC

    Manufacturers have used a quality systems approach to ensure consistency within their processes for years, but the FDA is now encouraging clinical researchers to take a similar approach to medical device trials.

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  • 4 Ways an EQMS Can Help You Improve Supplier Visibility

    9 January, 2018 by David Butcher, Staff Writer

    Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, according to MasterControl Senior Product Manager Terrance Holbrook.

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  • 5 Areas of Focus When Conducting Supplier Audits

    2 January, 2018 by David Butcher, Staff Writer, MasterControl

    Conducting supplier audits is a well-established way to identify, eliminate and prevent quality problems in a supplier’s products, processes or management system before the problems spread. Still, there are ways to improve supplier audits. In a recent article for Pharmaceutical Manufacturing, MasterControl Senior Product Manager Terrance Holbrook recommended five actions take to to better conduct onsite supplier audits.

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  • Is Your Medical Device Company Headed Toward a 483?

    28 December, 2017 by Marci Crane, Staff Writer, MasterControl

    Medical device companies that sell product in the United States should be ready at all times for a Food & Drug Administration (FDA) inspection. FDA inspectors have the authority to issue a 483 notice, which is officially referred to by the FDA as a “Notice of Inspectional Observations.” The seriousness of receiving a 483 should not be underestimated.

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  • 5 Most Common Pharma Form 483 Quagmires & How to Avoid Them

    26 December, 2017 by James Jardine, Staff Writer, MasterControl

    See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.

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