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GxP Lifeline
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    Avoiding a Time Traveler’s Mindset With CAPA Effectiveness Checks

    How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).

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    SPC vs SQC: The Strategic Difference

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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    Software as a Medical Device – Upcoming Changes to the Australian Regulations

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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    Nelson Labs on Adaptability and Communication in the Time of COVID-19

    Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.

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    Mind the Gap! The 3 Biggest Gaps Faced When Implementing IVDR

    If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.

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    Global 2020 Cannabis Trends

    Cannabis is legally and socially becoming more accepted worldwide. New regulations, new products and new technology are all helping the cannabis industry mature. In 2020, these trends are expected to shape the industry.

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    2019 Nutraceutical Trends: Relevant During COVID-19

    Five major trends hit nutraceuticals last year. For the most part, those trends played out as expected. What was not expected was for the year to end in the COVID-19 pandemic. We’d like to take a look at how the pandemic has changed last year’s trends and what the future likely holds for the nutraceutical industry.

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    How to Align Quality Across an Expanding Ecosystem

    As companies grow more reliant on geographically dispersed contractors, partners, vendors and business units, it gets harder to align quality across all the entities involved. Learn how global companies like Fagron maintain quality consistency across multiple sites and discover why connecting data and processes within a robust digital platform is the surest way to align quality across your entire ecosystem.

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    Having a Good Quality Culture Improves Your Data Integrity

    Data integrity is a high priority to both the pharmaceutical industry and regulatory authorities. To improve data integrity, it's critical to example the role of quality in your company culture.

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    Document Control Systems: The Cornerstone of Life Sciences Quality Management

    Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. An efficient document control system is at the core of quality management and good manufacturing practices.

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    What Verification and Validation Activities are Required for a First in Human Study?

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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    3 Ways CMOs Are Looking to Digital Technology to Improve Collaboration

    Rising demand for contract manufacturing organizations (CMO) necessitates growth to new locations throughout the U.S. and across the globe. The result of this expansion is increased production, but also a more complex supply chain, which requires digital collaboration with brand owners.

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    Three C’s That Will Matter for Manufacturers in a ‘Post-COVID-19’ World

    The time for manufacturers to prepare for a post-COVID-19 world is now. Re-calibrate for the ""new normal"" by looking to these ""three c's"" for guidance.

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    4 Steps to Integrate Technology Into Your Pharma Supply Chain

    An array of advanced technology and digitization are rapidly changing the landscape of pharmaceutical manufacturers and their supply chains. Mukul Dakwale, principal consultant at Luceats, explains how formulating a digitization strategy and implementation plan can help your pharma company transition from disparate, manual data systems toward end-to-end automation.

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    Overcoming Minimalism to Elevate Manufacturing Quality

    The philosophy and cultural of minimalism and “settling” can be disadvantageous when it comes to quality manufacturing standards and expectations. Jim Leonard, a senior consultant with QSG, presents quantitative and qualitative analysis of how such approaches can stagnate quality and shares tips on how to achieve a high level of continuous improvement in manufacturing.

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  • 2020-bl-thumb-qserveeu-mdr-update

    EU's MDR Extended: Where Do Medical Device Manufacturers Stand?

    The much-anticipated one-year delay of the European Union’s Medical Device Regulation (MDR) finally dropped earlier this month. Gert Bos, Executive Director and Partner of the Qserve Group, breaks down what this means for device manufacturers and for their preparations to recertify under the new regulation through a designated Notified Body.

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    A Heartfelt Thank-You to Our Customers

    In response to COVID-19, our customers and so many others are working hard on the front lines, behind the scenes, and everywhere in between. From everyone at MasterControl: Thank you!

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    Weighing FDA's Response to the COVID-19 Pandemic

    The rapid global spread of the coronavirus caught many world governments and health authorities off guard. Gina Guido-Redden, co-founder and COO of Coda Corp USA, offers a comprehensive review of the how the U.S. Food and Drug Administration (FDA) has responded thus far to the pandemic under 21 CFR.

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  • 2020-bl-thumb-data-integrity-and-21-cfr-part-11

    How Harmonizing 21 CFR Part 11 and Data Integrity Delivers Higher Quality Products

    Complying with the many record and data management requirements for 21 CFR Part 11 and data integrity can be daunting. In this article, Matt Brawner, data integrity subject matter expert (SME) at Sequence Inc., explains how companies can integrate Part 11 and data integrity processes to accelerate pathways to approval and deliver higher quality products to market.

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    How to Conduct a Well-Controlled Clinical Trial

    Successful clinical trials are a critical stage in the product life cycle of any life sciences product. Brandy Chittester, president of IMARC Research, outlines how manufacturers can conduct well-controlled trials that meet regulatory compliance and delineates pharmaceutical trials from those of the medical device industry.

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