Showing items tagged as Blood & Biologics

  • How to Respond to FDA Inspection Observations, Including Those You Dispute

    26 January, 2016 Martin Browning, President, EduQuest, Inc.: FDA expert investigator and rule-maker for 22 years

    Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

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  • 6 Ways Quality Managers Can Build a Culture of Quality

    12 January, 2016 Beth Pedersen, Marketing Communications Specialist, MasterControl

    If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?

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  • Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

    1 December, 2015 Jessica Masarek, Quality Assurance Consultant | Independent Auditor Director, Muse Clinical

    Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen. What if I say the wrong thing? What if I don’t know the answer? What if I can’t provide what they are asking for? Realistically, all of these things will probably happen! That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection. We are expecting transparency. As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data. Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted. An inspector has a similar goal with respect to the assessment of trial conduct. So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?

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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 5 Tips for Winning Executive Buy-In for a New QMS

    26 May, 2015 Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

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  • Fewer Donor Hearts Used

    21 April, 2015 Sheila Yu, dailyRx News

    As the waiting list for heart transplants has grown longer, fewer hearts have become available for transplantation in the US in recent years.

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  • Regulatory Tools Go UFO: Useful, Free & Online

    7 April, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations.  Indeed, that’s why many people stay away.  But if you can tolerate a little noise, I’ve found that the fruitful far outweighs the fruitless.  Case in point:

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  • Why Do You Do What You Do?

    31 March, 2015 Jon Beckstrand CEO, MasterControl Inc.

    Have you ever asked yourself why you do what you do? When you find yourself buried in quality procedures and SOPs, or embroiled in a heated meeting over incomplete CAPA tasks, do you ever question the meaning of your work?

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  • Did the Titanic Follow ISO 31000 Risk Management Guidelines?

    19 March, 2015 David Patrishkoff, President, E3

    ISO 31000 (Risk Management) and its supporting publications encompass an impressive and useful "to-do" list of risk management guidelines to create and protect the value of an organization. However, if an organization selectively pursues some of the ISO guidelines and ignore others, highly undesirable events and tragedies can occur.  This is what happened with the Titanic.

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  • The Journey to Supply Chain Excellence

    12 March, 2015 Ed Rausch, VP of Global Marketing, Elemica

    Some goals haven’t changed. Businesses in 2015 still have the common pursuit of growing revenues, profits, and market space, and leading companies are relying on building collaborative relationships in their extended supply chains to meet these goals in a responsible and sustainable way. Building powerful and more intimate relationships, extending across a critical mass of trading partners, leads to continuous improvements in company performance, agility, and differentiation.

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