Showing items tagged as Quality

  • 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: 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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  • 2020-bl-connected-quality-avoid-bottlenecks_132x132

    Give Thanks for Better Document Control

    There are multiple things that make Thanksgiving stressful. Relatives and food immediately come to mind. The level of orchestration required to pull off a successful Thanksgiving dinner is ridiculous. While we can’t make it easier to manage a successful Thanksgiving, there are ways to simplify your document management using artificial intelligence (AI) and advanced analytics.

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  • 2020-bl-5-w-of-quality-agreements_132x132

    Quality Agreements With Contract Manufacturing Organizations (CMOs)

    Life sciences companies are growing increasingly reliant on contract manufacturing partners as they strive to compete in a fast-paced and continually evolving industry. From the FDA’s perspective, those partnerships mean that both product owners and their contract facilities are responsible for CGMP compliance. Learn how quality agreements help both parties cover all their compliance bases.

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  • 2020-bl-using-connected-quality_132x132

    Using Connected Quality to Track Down Problems

    Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.

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  • 2020-bl-matt-brawner-qa-part2_132x132

    An Expert Explains Data Integrity and Organizational Excellence – Part Two

    Data integrity is an integral part of organizational excellence. An expert explains why companies need to align their efforts with customer needs, one of which is adhering to all applicable regulations. Common mistakes around 21 CFR Part 11 are explored along with ways to avoid them.

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  • 2020-bl-tool-continuous-improvement_132x132

    Quality Audit—A Tool for Continuous Improvement and Compliance

    Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.

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  • 2020-bl-coda-corp-vaccines_132x132

    The Fundamentals of Immunization, Part 2

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization.

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  • 2020-bl-thumb-4-reasons-documentation-is-critical_thumnb

    Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    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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