• Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

    25 July, 2017 by Jamie Arnott, Project Director and Caitlin Hirschman, Clinical Team Lead, Rho

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

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  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 by UL

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you 

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  • UDI as Med Device Product Tracking Software (Why That’s a Good Thing)

    1 August, 2017 By Cindy Fazzi, Staff Writer, MasterControl

    When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?

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  • Is the 510(k) Process as Worthless as the Federal Courts Seem to Believe?

    3 August, 2017 by Jeffrey K. Shapiro, Director, Hyman, Phelps, McNamara, P.C.

    Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says 

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  • 6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

    8 August, 2017 by Alex Butler, Manager Medical Device Solutions, MasterControl

    Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers

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  • Regulatory Strategies for AI and Emerging Technologies

    14 August, 2017 by Steve Tyrell, Senior Director, Business Development, Regulatory Compliance Associates Inc. and Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.

    Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher, Staff Writer, MasterControl

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • Nuts and Bolts of 510(K) Submissions

    17 August, 2017 by Rob Packard President, Medical Device Academy, Inc.

    A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.

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  • Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

    22 August, 2017 by James Jardine, Staff Writer, MasterControl

    At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider

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  • Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference

    24 August, 2017 by Stephanie Gaulding, CQA, CPGP, DPS Engineering

    I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.

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  • Four Things You Need to Know About FDA's Guidance for Tissue Establishments

    13 April, 2017 MasterControl

    FDA Reminds Manufacturers About Their GTP Responsibilities

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  • MasterControl Electronic Quality Management Software Solutions Benefit a Wide Range of Industries

    4 November, 2013 James Jardine

    For more than two decades MasterControl software has made it possible for hundreds of companies in an extensive array of industries across the globe to improve quality processes and get products to market more quickly. Companies doing business in regulatory environments in particular use MasterControl solutions to ensure sustained compliance and stay ahead of competitors.

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  • Five Common Issues that could Jeopardize Training Compliance

    9 December, 2014 Cindy Fazzi, Staff Writer

    If your company is regulated, then you know that it’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work.

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  • The Most Treacherous Evil Villains and the Software They Won’t Let You Buy!

    2 August, 2016 MasterControl

    Villains, like their heroic counterparts, have interesting and complex pasts. Their complexity can be strange at times and is often hard to comprehend. After all, they generally want to kill pretty much every living creature and that can be somewhat uncomfortable for “normal” humans to process. However, taking a look at a villain’s back story and his recurring behavior can help average human beings understand why villains are constantly trying to destroy love, joy, beauty and oh yes, that professional software you’re about to purchase.

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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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  • QA is Like Pro Soccer and 4 Other Things You Might Not Know About QA

    11 August, 2016 Beth Pedersen

    1979 was a pretty momentous year. The Sony Walkman made its debut, Michael Jackson released his breakthrough solo album, “Off the Wall,” and Margaret Thatcher became the first woman in history to be elected as the British prime minister (more on Thatcher in a minute). But anyone who works in quality will remember 1979 for another reason altogether: the introduction of the term “quality assurance” (QA) in FDA’s 21 CFR Part 58 (1), also recognized as the first Good Laboratory Practice (GLP) regulation.

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  • 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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  • If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

    23 August, 2016 by Marci Crane, Localization Manager, MasterControl, Inc.

    The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

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  • 10 Things I Wish I’d Known Before Writing my FDA Response Letter

    25 August, 2016 Lisa Weeks

    If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days!

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  • UDI: When the Rule is Not Enough

    30 August, 2016 MasterControl

    With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

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