Showing items tagged as Quality

  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.

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  • 2021-bl-audit-checklists_132x132

    Understanding Auditor Checklists to Help Prepare for Audits and Inspections

    A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.

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  • 2021-bl-quality-assurance-quality-control_132x132

    Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?

    Quality assurance and quality control aren’t identical or interchangeable. Comparing the two functions to television’s most enduring police crime drama might help you explain their differences to your peers.

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  • 2021-bl-career-in-quality-management-pt-2_132x132

    Pursuing a Career in Quality Q&A — Part 2

    The quality management career has its ups and downs. We’ve already explored how to get into quality — now Quality Engineer Natalie Weber shares the good, the bad, and the hilarious parts of the job.

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  • 2021-bl-career-in-quality-management_132x132

    Pursuing a Career in Quality Q&A — Part 1

    The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.

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  • 2021-bl-coda-corp-quality-personnel_132x132

    Think Systems: Cause Quality

    With the right system, you can achieve and sustain a high level of quality. This includes having the ability to capture objective, up-to-date information so you can make data-driven decisions.

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  • 2021-bl-quality-inspiration_132x132

    Quality Inspiration: 5 Quality Quotes for Industry Professionals to Consider

    For professionals in the business of quality, inspiration can be found in all sorts of ways, from studying other industries to browsing the patent office or even taking a different route to work. A simple but often motivating approach is to look to words of wisdom from experts in their fields. Here are five insightful quotations, from a variety of fields, that carry quite a bit of truth for quality professionals.

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  • 2020-bl-2020-qa-vs-qc_132x132-main-thumb

    Get Quality Clarity: Your Guide to Understanding Quality’s Interactive Elements

    To actualize quality, you first must define the concept and clarify its objectives. Explore the relationships between the various functions that contribute to the overall quality management system (QMS) and learn about the critical role digital tools play in helping companies meet their quality goals.

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  • 2021-bl-fda-eu-inspections_132x132

    FDA vs. EU Inspections: Similarities and Differences

    In 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched an initiative to harmonize regulatory supervision of clinical trials. It streamlines collaboration and information sharing between the two regulatory bodies on good clinical practice (GCP) inspections. Quality and compliance expert Maria Dorat gives an update on the initiative and explains how harmonization is working during COVID-19.

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  • 2021-bl-sue-marchant-plenary_132x132

    2021: The Year for Insights Into Quality Data

    The new year might turn out to be just as unpredictable as the old. But, there’s one thing that we at MasterControl have full confidence in: Quality data will become more accessible and provide more insights than ever before.

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  • 2021-bl-global-regulatory-strategy-plan_132x132

    How to Create an Effective Global Regulatory Strategy and Plan

    An integral part of remaining compliant is having and maintaining a strong global regulatory strategy. Before diving in and creating a strategy, understand what to include so it’s effective. A global regulatory strategy ultimately saves your organization time and money while making it possible to get product to market more quickly.

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  • 2020-summit-keynotes-overview_132x132

    Virtual Masters Summit 2020: Digital Transformation and Data in a Time of Uncertainty

    Every organization is dealing with a deluge of data and the challenges of uncertainty. Companies are drowning in data but starving for insights in a time of rapid change, both domestically and globally. What’s needed is the ability to easily access, analyze and apply data in real-time to current challenges, while using the information to better plan for and shape the future. At Virtual Masters Summit 2020, two thought leaders highlighted ways that emerging technology and data can help life sciences organizations move forward during uncertain times.

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  • 2020-bl-six-steps-qualifying-suppliers_132x132

    Five Best Practices for Ensuring Supplier Quality

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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  • 2020-bl-cqg-quality-mgmt-trends_132x132

    Three Quality Management Trends to Watch in 2021

    Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.

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  • 2020-bl-2020-qa-vs-qc_132x132

    Quality Assurance, Quality Control and Quality Management: Clarifying Confusion

    With so many similar sounding terms related to quality in life sciences manufacturing, it’s easy to get confused about their definitions and intersections. Learn the purposes of quality assurance, quality control and quality management, their overlap and the differences between each critical function.

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  • 2020-bl-enterey-software-adoption_132x132

    Looking to Adopt Technology? Look at Processes First

    Managing Consultant for Enterey, John Chiechi, explains that before adopting new technology, a business must have the right processes in place.

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  • 2020-bl-pharma-quality-by-design_132x132

    What Is Pharmaceutical Quality by Design?

    Approximately one out of every 10 drug products make it to market. Pharma companies are striving to improve that statistic by implementing more effective quality and risk management measures. Quality by Design (QbD) is one of those measures and it’s becoming more widely adopted by manufacturers in the life sciences industry.

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  • 2020-bl-coda-corp_132x132

    The Fundamentals of Immunization, Part 3

    Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.

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  • 2020-bl-using-connected-quality_132x132

    What Connected Quality Means for Training

    For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.

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  • 2020-bl-world-quality-day_132x132

    Celebrating Quality Mastery (and Mishaps) on World Quality Day

    World Quality Day 2020 provides the ideal opportunity to celebrate quality professionals who go above and beyond. It’s also a good time to have some LOLs about the quality world’s more comical and cringeworthy experiences. Giggle (or groan) along with the entries in the Quality Shorts Film Fest, and find out who won the 2020 Masters of Excellence Awards.

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