GxP Lifeline

 

  • The CAPA Detective

    3 September, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Every industry has its detectives. Mechanics and journalists hunt for leaks. Software testers and security experts look for bugs. Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore. The level of intrigue may vary.

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  • The Patient is Missing

    1 September, 2015 Amy Musolino, Program Director, New Service Development, Fisher Clinical Services

    Recently, I had the opportunity to attend a presentation by Patricia Larrabee, CEO and founder of Rochester Clinical Research. While there, I couldn’t help reflecting on the truly significant contribution that patients play in the success of clinical research. Furthermore, what a burden we often inadvertently place on them as well as our investigator sites.

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  • OMG! The FDA Is Keeping Up With Kim Kardashian, Too

    28 August, 2015 Alex Butler, Product Manager, Life Science Applications (LS APPs), MasterControl

    Love her or hate her, reality-star Kim Kardashian knows how to get our attention. Whether she’s trying to break the Internet with risqué photos or agonizing over which Rolex to wear, people are watching. Kardashian boasts more than 34 million Twitter followers; 26, 074, 878 likes on her Facebook fan page; and 42 million Instagram followers. Forty-two million! That’s how many people may have seen her infamous July 19 Instagram post praising the morning sickness drug Diclegis® that landed her and drug maker Duchesnay in hot water with the FDA. “Kim Kardashian’s greed finally got the better of her,” the author of one op-ed piece for the popular U.K. tabloid the Mirror gleefully exclaimed.1 I’m not so sure. Perhaps Kim Kardashian is smarter than we think.

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  • FDA Requests Public Input on Quality Metrics Guidance

    27 August, 2015 Oliver Wolf, Senior Product Manager, MasterControl

    In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points.

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  • Three Things I’ve Learned about Quality Professionals

    26 August, 2015 Jon Beckstrand, CEO, MasterControl Inc.

    Over the past 15 years, as the leader of an organization dedicated to improving the success of the quality profession, I have met hundreds of people throughout the world who have a unique mission: build greater quality into the things we use every day. I have often asked myself, what do all these people have in common? What makes someone choose to dedicate his or her career to improving quality? Who are these people who dedicate their lives to making sure that things are done right, that we don’t skip critical steps? Whether it’s making sure that you aren’t using yesterday’s version of a work instruction or that you are trained properly on changes crucial to the implementation of a corrective action, quality professionals are ever vigilant about maintaining quality standards and compliance.

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  • Infographic: FDA Inspections By The Numbers

    25 August, 2015 Tony Chen, CEO and Co-Founder of FDAzilla

    Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection?

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  • Education And Corrective Actions: The Solid Foundation Of Food Safety Culture

    20 August, 2015 Sam Lewis, Associate Editor, Food Online

    There is no doubt about it; it is getting more and more difficult to be a successful food processor or manufacturer. The supply chain continues to grow and become more complex, food safety regulations across the globe are becoming increasingly stringent, consumer preferences are constantly evolving, and the food industry’s workforce seems to be continuously changing. All of these trials amplify the importance of managing risks, keeping the public safe, and maintaining consumer loyalty to your brand. So, what can you do to manage this incessantly-growing number of risks?

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  • 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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