Showing items tagged as Pharma
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise.
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There are many benefits for organisations gaining certification and for those organisations that are currently certified, ensuring those benefits continue to be realised is very important. Below I look at the benefits of certification and also what are the benefits of keeping abreast of upcoming changes in standards.
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Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement. With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.
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Thanksgiving in the USA is a wonderful time of year when we are reminded of everything that we have and how lucky we are to have it. We express our gratitude for what we have, where we live and those we love.
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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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