Showing items tagged as Pharma

  • 10 Tips for Enabling Better CRO-Sponsor Collaborations

    19 October, 2016 Craig Morgan, Head of Marketing goBalto, Inc.

    By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.

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  • Renowned Physician Patch Adams Urges Techies to Help Build an Ethical World

    18 October, 2016 Cindy Fazzi, Editor, MasterControl Insider

    Patch Adams, the physician famously played on the silver screen by Robin Williams, urged IT professionals to help build an ethical and nonviolent world during his keynote speech at the 2016 Masters Summit in Salt Lake City.

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  • Tweet This — If You Want to be Slapped with an FDA Warning Letter

    27 September, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers.

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  • Identifying and Preventing Common Data Integrity Issues

    20 September, 2016 Joanna Gallant, Owner/President, JGTA LLC

    Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.

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  • "Hacking" Quality

    13 September, 2016 Peter Holtmann, President & CEO, Exemplar Global Inc.

    Continuing my theme of the future of quality, the ability to see the future could come through some interesting lenses—hacking, for instance.

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  • Free E-Book Depicts a Decade of Change in Life Science Regulatory Compliance

    6 September, 2016 Cindy Fazzi, Staff Writer

    Which came first, the chicken or the egg? This dilemma applies to automation and regulatory compliance. Did the FDA issue 21 CFR Part 11 to encourage technology use? Or did life science companies use technology first—prompting the FDA to develop corresponding regulations?

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  • If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

    23 August, 2016 by Marci Crane, Localization Manager, MasterControl, Inc.

    The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

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  • Why Russia Is an Attractive Market for Clinical Trials

    16 August, 2016 MasterControl

    When you think of countries as candidates for clinical trials, which ones come to mind? North America, Great Britain, France?

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  • Leverage the Power of SOPs

    4 August, 2016 Cindy Fazzi, Staff Writer

    Most companies establish standard operating procedures for compliance purposes, but that’s just the start and it doesn’t leverage the power of SOPs, according to Lillian Erickson, MasterControl’s global quality manager, in a recently published article in Fleet Maintenance magazine.

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  • A Warehouse Love Song

    26 July, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Storing stuff doesn’t sound like it should be difficult, but complying with FDA’s detailed regulations for warehousing pharmaceuticals can be. To start, your warehouse has to be clean and pest-free. Dirt, insects, lubricants, or other agents could compromise the packaging or prevent labels from adhering. Your facility also needs proper drainage, ventilation, adequate space, and work lighting. (Is your warehouse susceptible to flooding? Do cramped or dark conditions increase the likelihood of dangerous product mix-ups?) You also have to make sure your product is not exposed to more heat, cold, humidity, or light than stability testing recommends. (Do you have moisture and temperature sensors throughout? Is the heat tunnel you use for sealing shrink wrap too hot? Do you have backup refrigeration? Have all of these devices been cleaned, serviced, inspected, and calibrated?) And what are your procedures if you find any safety threshold has been exceeded? Are your people adequately trained?

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  • The Proper Role of the FDA in the 21st Century

    21 July, 2016 Dr. Joseph Gulfo, Executive Director, Rothman Institute of Innovation & Entrepreneurship

    The current medical marketplace is vastly different from the marketplace that existed when the basic elements of Food and Drug Administration law were passed. Despite rapidly advancing technology and patients’ increasing desire to try new drugs and devices, the FDA has strayed significantly from the statutorily defined safety and effectiveness standards for drug approvals. The FDA now very often demands proof of clinical utility, including survival and disease outcomes, as a requirement for premarket approval. But hard proof of clinical utility is elusive, even for drugs that are clearly shown to be safe and effective as labeled. Rather than blocking safe and effective drugs on such grounds, we should allow physicians and patients to make outcome-oriented decisions, and rely on the medical marketplace to drive physician adoption of safe and effective drugs that prove to have great clinical utility in real-world settings.

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  • Your Suppliers’ Risk Is Your Risk

    14 July, 2016 By Carrie Mantey

    In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.

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  • What Will Quality Look Like in 20 Years?

    12 July, 2016 Peter J. Holtmann, President and CEO, Exemplar Global

    To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”

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  • What, No Internal Audits?

    21 June, 2016 Dr. Christopher Joseph Devine, President Devine Guidance International

    For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.

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  • Six Steps to Qualifying Suppliers

    16 June, 2016 by Robert Packard, Packard Consulting

    Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

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  • The Dude Abides! 5 Quotes from “The Big Lebowski” that Apply to Quality

    14 June, 2016 Cindy Fazzi, Staff Writer

    “The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.

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  • 2016 Masters Conference in Amsterdam Sheds Inspiring Light on Quality

    7 June, 2016 Beth Pedersen, Marketing Communications, MasterControl

    Quality, regulatory, IT and management professionals across pharmaceutical, medical device, biotech and manufacturing came together for two days of learning and networking last month in the friendly host city of Amsterdam. Now in its sixth year, MasterControl’s annual Masters Conference, held 11-12 May, offered the user community in Europe a chance to rub shoulders with industry experts, exchange knowledge and experiences with others in the same profession, and receive one-on-one consulting from the MasterControl team. From humorous to emotional and everything in between, the wide variety of presentation topics showed just how diverse and impactful the field of quality can be.

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  • Kaizen Means You Care

    2 June, 2016 Dan Markovitz, Markovitz Consulting

    I’m shepherding this company along its lean journey, and we’ve started by asking people to simply fix what bugs them. We’re not making people sit through lots of classes, we’re not doing 5S, we’re not trying to “move the needle” on the business—we’re just trying to get people to see that the way things were yesterday isn’t the way they have to be today. We want people to know that they have the power to make things better and easier for themselves. We often forget that’s the real first step in establishing a culture of kaizen—just knowing that you’re allowed to improve things.

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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  • SOP Revision SWAT-Style

    19 May, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.

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