background image for GxP Lifeline
GxP Lifeline
  • 2018-bl-thumb-know-what-you-dont-know-about-drug-development

    The Importance of Knowing What You Don’t Know About Drug Development

    New drug development is Sunday drive, especially for startups. There can be costly mistakes and unanticipated roadblocks that pop up when you least expect it. Learn how to steer clear of hazards, what to do and who to talk to.

    Full story
  • roadway-horizon-132

    "The Medical Device Single Audit Program: Accessing International Markets, Part 1"

    Regulatory change is a near constant in the medical device industry. One of the newest systems to the international medtech scene is the Medical Device Single Audit Program (MDSAP). Find out what is required to implement MDSAP in this first of a three-part series

    Full story
  • 5G-abstract-cityscape-132

    How Supervillains Could Benefit From a Manufacturing Operations Solution

    In the epic good vs. evil paradigm in superhero movies, supervillains could actually improve their odds if they used the right technology. This article looks at three noted supervillains and discusses how their nefarious agendas might have been more successful had they used a digital manufacturing operations solution.

    Full story
  • 2018-bl-thumb-pwc-logo

    PwC Report Analyzes Health Care Policy Issues

    PwC’s Health Research Institute recently issued a report on the U.S. midterm election that analyzes policy issues that may well impact the American health care industry for years to come, particularly those in the pharmaceutical and life science industries. Learn what this means for manufacturers.

    Full story
  • 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.

    Full story
  • 2018-bl-thumb-top-5-nutraceutical-trends-in-2-2018

    Top 5 Nutraceutical Trends in 2018 - Conducting Clinical Trials on Nutraceuticals

    Nutraceutical companies have never been required to conduct clinical trials. However, many are now voluntarily taking on this endeavor to show that their products work as advertised. This adds legitimacy to nutraceuticals and provides a better value for consumers, but the complexity of clinical trials presents a significant hurdle.

    Full story
  • 2018-bl-thumb-raps-logo

    Advancing the Regulatory Profession in Utah

    Based on recent economic study and the establishment of the Silicon Slopes technology corridor, Utah has one of the fastest-growing life sciences communities in the U.S. Learn about the Regulatory Affairs Professionals Society’s (RAPS) new Utah Chapter and what the organization is doing to attract more regulatory affairs experts to life sciences careers.

    Full story
  • 2018-bl-thumb-top-5-nutraceutical-trends-in-2018

    Top 5 Nutraceutical Trends in 2018 - Getting Creative With Protein

    The protein supplement category is no longer exclusively for hardcore athletes. The general population is now full of people who are concerned that they’re not getting enough protein in their diets. These consumers are increasingly turning to supplements to fill the void.

    Full story
  • smart-document-contract-132

    De Novo Becoming Faster and Easier Pathway to Market

    There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.

    Full story
  • 2018-bl-thumb-whats-hiding-in-your-labeling-artwork

    What's Hiding in Your Labeling Artwork?

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

    Full story
  • warehouse-worker-supplier-quality-132

    Advancing the Case for Quality in Medical Device Manufacturing

    We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.

    Full story
  • 2018-bl-thumb-braveheart-team-emphasizes-quality-first-approach

    BraveHeart Team Emphasizes Quality-First Approach

    One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.

    Full story
  • 2018-bl-thumb-fmea-without-tears

    FMEA Without Tears: A Prescription to Reduce Pain and Confusion

    Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.

    Full story
  • 2019-bl-thumb-braveheart-update-tl

    Airplane Preflight Check Exemplifies Quality in Med Device Design

    Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.

    Full story
  • 2018-bl-thumb-shifting-reimbursement-landscape-australia

    Getting Paid: A Shifting Medical Device Reimbursement Landscape in Australia

    Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.

    Full story
  • 2018-bl-thumb-exploring-nutraceuticals-delivery-options

    Top 5 Nutraceutical Trends in 2018 - Exploring Different Delivery Methods

    The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.

    Full story
  • 2018-bl-thumb-braveheart-patch

    Med Device Company Takes Flight With Life-Changing Innovation

    Startup ventures are the embodiment of innovation – often hitting the ground running with little more than an idea and a vision. Part one of this three-part series introduces startup medical device company, BraveHeart Wearable Life Sensors, and how it is uniquely inspired by aviation.

    Full story
  • artificial-intelligence-132

    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.

    Full story
  • 2018-bl-thumb-medtech-europe-urges-european-commission

    How Approaching MDR/IVDR Deadlines Are Impacting Med Device Industry

    The countdown to the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) deadlines is underway. However, transition issues are creating a logistical logjam for both the medical device industry and the European Commission (EC), which is impacting the med device industry. MedTech Europe still wants the EC to stop the clock.

    Full story
  • 2018-bl-thumb-regulatory-new-digital-pathway

    New Digital Pathways Boost Success Rate of Med Device Introductions

    Launching a med device always has a sense of urgency. However, failing to gain market approval or facing a recall can be costly. You avoid these scenarios with new digital pathways that facilitate faster and more efficient regulatory information management (RIM) and product life cycle development.

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