Showing items tagged as quality management system

  • 2020-bl-future-trends-opportunities_132x132

    Future Trends and Opportunities in Quality Assurance

    At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.

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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-nelson-labs-respirator_132x132

    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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  • 2020-bl-thumb-8-system-requirements-ext-quality-across-ecosystems

    8 System Requirements for Extending Quality Across Expanding Ecosystems

    More and more life sciences companies are adopting asset-light models that heavily rely on a broad system of contract organizations. When supply chains expand, however, quality is often the first casualty. Learn the key questions to ask to ensure your system can enforce quality across the entire ecosystem.

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  • 2019-bl-thumb-3-critical-keys-integrated-management

    3 Keys to Implement an Integrated Management System With ISO 9001

    Life sciences companies that implement an integrated management system (IMS) can provide both improved compliance with ISO 9001:2015 while also better aligning your organization’s quality system and business model. Learn how to harmonize your systems.

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  • 2018-bl-thumb-creating-an-audit-ready-qms

    Building an Audit-Ready QMS

    Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.

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  • MasterControl Logo

    Expert Tips on Enhancing CAPA Through Innovation

    This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.

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  • 2018-bl-thumb-leveraging-value-quality-business

    Leveraging the Value of Quality in Your Business Through ISO

    Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.

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  • 2018-bl-thumb-ai-on-the-cusp-of-revolutionizing-pharmaceuticals

    Artificial Intelligence: Is It on the Cusp of Revolutionizing Pharmaceuticals?

    One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.

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  • 2018-bl-thumb-top-5-med-device-industry-trends-software complex

    Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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  • 2020-bl-thumb-align-quality-across-ecosystem_132x132

    What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

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  • 2017-bl-author-wolfgang-schmitt

    How to Become a QP in Europe

    Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?

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  • ISO, Regulatory Requirement Changes Loom

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • The Most Important Four-Letter Words in ISO 9001:2015

    Most organizations are well under way with the transition to the new ISO 9001:2015.  As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….

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  • GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

    In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”

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  • ISO 13485:2016 What are the Changes About?

    ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.

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  • How to Ensure You are Following the ISO 9001 Certification Process

    How to Ensure You are Following the ISO 9001 Certification Process

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  • 5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

    The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.

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  • What Do You Do? A Short and a Long Answer

    I was recently asked point-blank: What does MasterControl do? I was being interviewed for a medical device publication’s podcast, so the question was expected. Still, it forced me to mull over the company’s mission and accomplishments in the past 13 years under my leadership.

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  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

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