• 2018-bl-thumb-newly-approved-dietary-fibers-in-supplements

    Using the Newly-Approved Dietary Fibers in Supplements

    Many consumers don't get enough fiber, leading to health problems that are especially prevalent as people get older. Fiber supplements can help fill the gap, and now the FDA has expanded its definition of dietary fiber to include eight more sources.

    Full story
  • 2018-bl-thumb-manufacturing-software-trends-july-2018

    The #1 Gap in Manufacturing Software Today

    It’s 2018 and technology has pervaded every area of our lives. Yet a visit to almost any manufacturing floor reveals that paper is alive and well, even in forward-thinking companies with strong IT strategies and digital transformation initiatives in place. Why is it that the truly paperless factory floor remains so elusive?

    Full story
  • 2018-bl-thumb-gxp-lifeline-regulatory-manager

    Regulatory Manager Tip: Making Your Voice Heard at the FDA

    As a life science manufacturer, how can I minimize risk and hiccups before seeking U.S. Food and Drug Administration approval for my product? Learn how to make your voice heard at the FDA in this month’s Regulatory Manager Tip.

    Full story
  • 2018-bl-thumb-how-ai-tools-transform-quality-mgt-in-life-sciences-part-2

    How AI Tools Will Transform Quality Management in the Life Sciences, Part 2

    The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers. Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.

    Full story
  • 2018-bl-thumb-how-ai-tools-transform-quality-mgt-in-life-sciences-part-1

    How AI Tools Will Transform Quality Management in the Life Sciences, Part 1

    FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.

    Full story
  • 2018-bl-thumb-clinical-trends-med-device

    Noteworthy Clinical Trends in Med Device to Watch in 2018

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

    Full story
  • 2020-bl-mc-insights-01_132x132

    Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

    Full story
  • 2018-bl-thumb-top-5-med-device-industry-trends-atypical tech-2

    Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

    Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.

    Full story
  • 2018-bl-thumb-gxp-lifeline-regulatory-manager

    How to Make Pre-Sub Program Communication With the FDA More Transparent

    If you're getting close to submitting a medical device for market clearance through the FDA, you may want to read this month's Regulatory Manager Tip. The best type of communication for this process is to create even greater transparency by creating a venue for interaction with FDA staff for a "pre-sub" review of your device submission.

    Full story
  • 2017-bl-thumb-what-is-doc-control-system

    What Biotech Startups Need to Do to Slay the Competition

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

    Full story
  • 2018-bl-thumb-mc-top-clinical-pharma-bio-trends-to-date

    2018’s Top Clinical Pharma/Bio Trends to Date

    Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.

    Full story
  • 2020-bl-vaccine_132x132

    Medtech Startups: How to Survive Cutthroat Competition

    In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.

    Full story
  • 2018-bl-thumb-what-the-new-ruling-means-for-caffeine-supplements

    What the FDA’s New Ruling Means for Caffeine Supplements

    Most of us need caffeine to get through the day, whether from coffee, soda or energy drinks. For those seeking alternate sources, nutraceutical companies have been happy to oblige. However, recent headlines about dangerous caffeine supplements and subsequent action by the FDA might be worrisome to consumers and manufacturers.

    Full story
  • 2020-bl-manufacturing-excellence-03_132x132

    Building a Vendor Qualification Program for FDA-Regulated Industries

    A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.

    Full story
  • 2018-bl-thumb-gxp-lifeline-quality-manager

    Time Management: Walk the Talk, QA Professionals!

    Quality assurance professionals are experts when it comes to talking about time management. But how to they fare in practice? Find out in this month's Quality Manager Tip by Walt Murray.

    Full story
  • 2018-bl-thumb-tga-process-conformity-assess

    TGA Process for Conformity Assessment in Australia

    If you’re considering the Australian market for your medical device product and don’t have CE marking, the conformity assessment is an ever-increasing opportunity to enter the market. Furthermore, with the ever-changing landscape in Europe, many would suggest that Australia's Therapeutic Good Administration (TGA) is a well-established and understood pathway, whereas the European market is becoming somewhat more challenging and less understood.

    Full story
  • 2018-bl-thumb-fda-back-cannabis

    FDA Backs Cannabis-Based Drug to Treat Kids With Epilepsy

    Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.

    Full story
  • 2020-bl-connectivity-02_132x132

    The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

    Full story
  • 2020-bl-connectivity-03_132x132

    The Link Between Regulation, Quality Systems and Data Integrity, Part 1

    The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.

    Full story
  • 2018-bl-thumb-fda-top-10-gmp-inspection-citations-2017-part2

    FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]