GxP Lifeline

 

  • ISO 9001:2015 – The Best Thing for Top Management Since Ambien

    18 August, 2015 Matt Leiphart, Cavendish Scott, Inc.

    The best top management sleep aid ever invented may be ISO 9001:2015. I’m not talking about the text, which induces Droopy Eyelid Syndrome. The biggest changes in the new version of ISO 9001 are designed to address top management’s concerns BEFORE problems arise. When systems are in place to prevent problems, top managers feel safe, secure, cared for, nurtured, and they sleep like babies.

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  • Reimbursement: A Medical Device Company's Worst Nightmare?

    12 August, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    In 2014, reimbursement trumped regulatory as the industry’s biggest concern.1 As we move further into 2015, it remains at the forefront of stakeholders’ minds. In its 2015 Medical Device Industry Survey, Emergo asked 636 presidents, CEOs and managing directors of medical device companies what issues were keeping them up at night, and reimbursement challenges ranked in the top three.2 In this era of health care reform, device makers are under intense pressure to develop products that demonstrate not only clinical efficacy, but also real value (i.e., lower costs and better outcomes) in order to secure coverage and attract risk-averse investors. In this post, we’ll examine some of the most common reimbursement policy challenges and discuss strategies for putting them to rest.

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  • Unique Device Identification (UDI): Much More Than Just a Label

    11 August, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

    Labels are everywhere. Virtually every manufactured item is labeled with product information, and even fresh produce from the grocery store often bears a scannable barcode and ID number. Not only are things labeled, but people, too – any visit to the hospital comes with a bracelet displaying your personal medical details, identification information and a barcode. For the most part, we have become so desensitized to barcodes and labeling information that we rarely pay it any attention; presented in the form of random lines and number series, it can seem completely meaningless to us.

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  • Why a Zombie Apocalypse Would Be Unstoppable with a QMS

    6 August, 2015 Marci Crane, Localization Manager, MasterControl

    Of the myriad ways in which the Earth’s inhabitants could potentially be destroyed, a zombie apocalypse (ZA) is undoubtedly one of the least impressive. Though a ZA is decidedly scary, unpleasant, and would “get the job done” as the un-romantic expression goes, it tends to lack the qualities and traits that truly cataclysmic destruction requires. These destructive qualities include intelligence, charisma and the ability to organize as a group.

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  • What Quality Really Means: Three Key Principles

    4 August, 2015 Lane Hirning, Product Management Director, MasterControl Inc.

    A friend of mine recently asked me to review his PowerPoint presentation for an upcoming investor conference, which I was happy to do. The first thing that struck me was his choice of fonts—different types and different colors. Second was the slide templates creating an inconsistent layout. It seemed like a trivial thing to point out, but I had to ask him: What kind of a first impression are you going to make with this presentation?

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  • My eQMS Consultant is Gone—Now What? 4 Post Go-Live Survival Tips

    30 July, 2015 Stephanie Jones, Senior Professional Services Consultant, MasterControl

    In my April 9, 2015 post, I offered eight tips for planning a seamless software go-live. This post picks up where that one left off to answer an important question many clients wrestle with after a successful go-live: What do you do when your software implementation consultant is no longer part of your day to day operations?

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 Kelly Thomas, Atlantic Validation

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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  • Quality Event Investigations, Interviews, and Brian Williams

    23 July, 2015 James L. Vesper, PhD, MPH LearningPlus

    If you are a follower of television news, you undoubtedly know of the problems that Brian Williams, the NBC television network news anchor experienced in early 2015. (If you hadn’t heard, he was found to have embellished his experience as a passenger as he was flying in a military helicopter in Iraq while covering a news story. He claimed his helicopter was hit by antiaircraft fire, when, in actuality, it was the lead helicopter; his aircraft was not affected [1].) In April 2015, it was reported that there were other exaggerations attributed to him [2].

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  • European Supply Chain: A Series of New Regulations in Force

    21 July, 2015 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

    The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some impact on revisions of several chapters of the EU-GMP Guidelines.

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  • Get Products to Market Sooner by Systematizing Quality Cycles

    16 July, 2015 by James Jardine, Marketing Communications, MasterControl

    It all starts with an initial idea developed with a collaborative team. Input is gathered from all the necessary sources and then tweaks to the original concept are made as needed. Many different types of reviews, approvals, and regulatory checks are also required during this development stage. Then it’s time to provide suppliers or vendors with specific orders to ensure all the puzzle pieces will fit together as planned. Once your organization’s employees receive all the training they need to make the product according to the specifications that have been devised it feels like you’ve almost reached the finish line. Now you just flip a switch and watch as the magic is made while you celebrate your magnificent accomplishment, right?

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  • eMDR Compliance Deadline Looms: Last Minute Tips for Procrastinators

    15 July, 2015 Alex Butler, Product Manager Life Science Applications (LS APPs), MasterControl

    In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format via the Electronic Submissions Gateway (ESG), rather than in paper form through Form FDA 3500A. The compliance deadline of August 14, 2015, is fast approaching! Will you be ready?

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  • Don't Just Fix It: Find It Before Your Customer Does

    14 July, 2015 Anna Thornton, Analytics Operations Engineering

    It is human nature to find a single cause of a problem, fix it, and assume everything is fine. In fact, the use of a scapegoat is documented in writings from four thousand years ago. All of the sins of a community were laid on the head of a single goat that was then driven into the wilderness, relieving every one of their problems. Four millennia later, we still believe in the power of the scapegoat to take away problems. When a product fails in the hands of the customer, triggering a recall or creating excessive warranty costs, companies quickly find a solution (or fire someone) and assume all is well.

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  • Ensuring Proper Training for Clinical Research Staff in Less Time

    9 July, 2015 Sandra Maddock, President & CEO, IMARC Research

    There has never been a more exciting time to be involved in clinical research. We’re seeing more advances in life-changing medical devices and pharmaceuticals than at any other time in history, creating a growing demand for qualified clinical research associates.

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  • It’s Hot in Here—Quality, Compliance, and Romance

    8 July, 2015 Cindy Fazzi, Editor, MasterControl Insider

    Sun, spice, and romance—they’re everything I associate with summer. And I’m not talking about your love life, but your quality system. Indulge me for a moment and let me talk about the two things—quality software and romance—that preoccupy me most. I’m a full-time marketing writer and a newly published romance author. By day, I write about quality and compliance. By night, I write about people who live happily ever after (known as HEA to romance readers).

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  • From Open Payments to OpenFDA, the Push for Global Transparency is Accelerating

    7 July, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    Transparency has been a hot topic in life science circles in recent years. So hot, in fact, that it has almost become a buzzword, which implies that it lacks real substance or staying power. Transparency advocates, who are pushing to make health industry data—everything from clinical trial results to procedure pricing information—more accessible, would disagree.

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  • Device Makers Urged to Ramp Up Their Security Efforts

    30 June, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    The Anthem data breach should be a wake-up call to the health care industry, according to security experts. On February 5, 2015, hackers stole the social security numbers and personal information of 80 million Anthem members and employees, leaving them vulnerable to identity theft and blackmail.1 While the insurer may be one of the biggest health care companies to suffer a breach, it certainly isn't the first.

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  • 4 Reasons Why Document Review is Crucial to Compliance

    25 June, 2015 Cindy Fazzi Editor, MasterControl Insider

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • Study: Doctors are Ready to Embrace mHealth Tools

    23 June, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl

    Mobile health, or mHealth, has gained significant momentum over the past couple of years, and it will continue to influence product development in 2015. Millennials raised on technology are providing device makers with the unprecedented opportunity to sell directly to consumers in the form of wearable devices and mobile health applications that allow patients and physicians to interact clinically from different locations. The popularity of mHealth tools has been fueled by the growth of the smartphone industry.

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  • How 3-D Printing is Revolutionizing Medical Devices

    18 June, 2015 Lisa Weeks, Marketing Communications, MasterControl

    Imagine a time when a clinician can modify and manufacture an implant sized for a particular patient on-demand in a health care facility—or print a human organ as easily as a paper document. As futuristic as it sounds, that time is not far off, according to scientists who continue to find new and truly mind-blowing ways to apply three-dimensional (3-D) printing techniques to the medical field.

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  • FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users

    11 June, 2015 Stacie L. Ropka and Chad A. Landmon Axinn, Veltrop & Harkrider LLP

    What does the Food and Drug Administration (FDA) consider to be “minimal manipulation” and how are human cells, tissues and tissue-based products (HCT/Ps) made from adipose tissue regulated by FDA? These questions were addressed in two draft guidances issued by FDA in late December of 2014. The first, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations (1), focuses on how adipose tissue is defined and thus how adipose-based HCT/Ps are regulated by FDA. The second, Minimal Manipulation of Human Cells, Tissues and Tissue-Based Products (2), focuses on the types of cell and tissue processing that would be considered more than minimal manipulation, resulting in the regulation of the cell or tissue-based product as a drug, biologic or medical device. Although they are not yet final, these guidances shed light on FDA’s current thinking and may signal that FDA will make it more difficult for products to be regulated solely under Section 361. Not only will such a position by FDA impact development of new HCT/Ps, but it could threaten the regulation status of currently marketed HCT/Ps.

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