GxP Lifeline

  • 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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    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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    EU’s MDR Calls for Summary of Safety and Clinical Performance (SSCP)

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

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    The Next Evolution in Manufacturing

    On 30 July 2020, we celebrated the 17th anniversary of the completion of the Human Genome Project (HGP). It took scientists 13 years to map and sequence all human genes, a staggering feat of modern science.

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    What Connected Quality Means for Training

    For regulated companies, there’s a whole lot riding on training. If someone isn’t trained or is trained improperly, the life-saving products of life sciences companies can become life-ending products.

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    The Platform Advantage: Keys to Keeping Up With Pharma’s Top 4 Trends

    To keep pace with the technological and scientific advancements that continue to shake up the pharmaceutical industry, companies are increasingly finding it necessary to adapt their strategies, procedures and business practices.

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    Cloud based QMS Launches in Australia

    MasterControl’s cloud-based quality management system (QMS) is now available in Australia. An increasing number of businesses are modernising their operations and discovering the advantages of cloud computing. Explore the ways cloud technology makes it possible to enhance your competitive edge.

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    Top Regulatory Trends Affecting Med Dev in Asia-Pacific Moving Into 2019

    Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.

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    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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    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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