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GxP Lifeline

Showing items tagged as Continuous Quality Improvement

  • 2021-bl-clinical-monitoring-reports_132x132

    How to Write a Useful Clinical Monitoring Report

    In clinical trials, site monitoring is required, but the report about the monitoring isn’t always given the attention it deserves. Prepare your next monitoring visit and the report by following these five tips to success.

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  • 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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  • 2017-bl-thumb-mobile-device-cybersecurity

    Cybersecurity in a Mobile World

    Mobile device technology appears to be taking off. Lately, it seems there are more non-phone-call uses for mobile devices than there are lightbulb jokes. The healthcare industry is becoming particularly mobile device heavy. However, in terms of cybersecurity, mobile medical device technology is causing headaches for healthcare organizations.

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  • 2017-bl-revisiting-capa-more-modern-approach-page-image

    Revisiting your Quality CAPA System for a More Modern (and Effective) Approach

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

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  • Developing a Quality System on a Managed Budget

    Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.

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  • smart-document-contract-132

    The Quality Metrics Journey

    One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.

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  • Quality by Design Part 1: You Can't Design Something You Don't Understand

    Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.

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