Showing items tagged as Pharma

  • 6 Traits You Should Develop to Become an Exceptional Quality Pro

    22 October, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros.

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  • Trust is Not Just Nice, It’s the Key to Your Success

    19 October, 2015 Cindy Fazzi, Staff Writer

    Whether you’re a quality professional responsible for your system implementation or a CEO getting ready to launch a medical device startup, Stephen M.R. Covey believes there’s one thing you need to succeed—trust. “Trust is an economic driver, not merely a social virtue,” he said in his keynote address at the 2015 Masters Summit.

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  • Personal PDCA and How I Learned It

    15 October, 2015 Mark Reich, Chief Operations Officer, Lean Enterprise Institute

    In 23 years at Toyota, I had many assignments and different bosses, I managed many people, but a constant part of the culture was what I’ve come to call “personal PDCA” – a kind of mentored self-development cycle. When it comes to personal PDCA, my first problem solving experience during my first-ever assignment in Japan stands out for me.

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  • Quality Audit: The Direct Route to Continuous Improvement

    6 October, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

    If your organization is GxP-regulated or ISO-certified, you are no stranger to the burdens of audit. The regulations and standards that govern your operations change often, and yet you must somehow manage to understand and comply with them – and be able to clearly demonstrate your compliance – at all times.

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  • Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

    17 September, 2015 Vivian Bringslimark, President & Owner, HPIS Consulting, Inc.

    The subtitle tells it all. Most employees don’t come to work with the intention to cause harm, fail or make mistakes intentionally. Yet mistakes, errors, and failures happen. According to Sidney Dekker, author of The Field Guide to Understanding Human Error, “mismatches between written guidance and operational practice always exist”. I’s due to “the amount of increasingly tight constraints of procedures” (p.8). There have been some occasions where following a procedure could have caused a deviation if it weren’t for an astute technician who questioned the “GMP” rule. Talk about a GMP dilemma, “always follow the SOP” but don’t create a deviation either. Alas, we have a classic example of a white hat hacker.

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  • Multipurpose Tool vs. Best-of-Breed Platform: How to Tell the Difference

    15 September, 2015 Paul Sanderson, Solutions Consultants Group Lead

    When we invest in tools, we naturally want the most bang for our buck. Who hasn’t tried to use a screwdriver as a pry bar or a pair of pliers for loosening a bolt when a properly sized wrench would be more appropriate?

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  • 6 Steps to Simplify Software Validation

    10 September, 2015 Kevin Ballard, Director of Software Validation, MasterControl

    Validation is one of the most time-consuming and resource-intensive activities when implementing eQMS software in a regulated environment, often delaying implementation and an organization’s ability to go live with new software.

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  • Building Forms for Regulated Environments: Top 10 Best Practices

    8 September, 2015 Cindy Fazzi, Editor, MasterControl Insider

    Whether you’re applying for a job or a loan, or registering for a conference or membership in some organization, there’s one thing you must do—fill out a form. We can’t live without forms. In regulated environments, they are even more crucial because they can affect regulatory compliance.

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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • Don’t Call Me Jim Cramer but Here are My Top 5 Pharma Trends

    3 June, 2015 Lane Hirning, Product Management Director, MasterControl Inc.

    Judging by a recent report forecasting future growth, the pharmaceutical industry is thriving despite the recent economic downturn. A market research firm is estimating a 30 percent increase in global medicine spending by 2018, which is great news for the industry (1). The same report cited the anticipated launch of 200 new revenue-boosting drugs within the next five years.

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  • Change in Pharmaceutical Manufacture

    28 May, 2015 Peter Murray, Consultant

    Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.

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  • How to Tip Off a GCP Auditor in 25 Words or Less

    21 May, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.

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  • Cosmeceuticals: the Good, the Bad and the Ugly

    19 May, 2015 MasterControl

    Since retiring from FDA, I have assisted numerous businesses in developing labels for “Cosmeceuticals.” I have also presented a number of training programs on the manufacturing and marketing of such products. When I was asked to write something using this specific title, I thought I would be able to quickly put an article together. At first, I had a difficult time putting pen to paper because I couldn’t think of anything “ugly” about cosmeceuticals as I define them. To get started I searched the Internet to see what others were saying about these products.

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  • The Bright Future of Quality and Compliance

    14 May, 2015 Craig Gygi, Executive Vice President, Operations, MasterControl Inc.

    Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?

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