GxP Lifeline

 

  • Modernizing the FDA's 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 2

    19 December, 2018 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This is Part 2 of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. This blog post discusses the pros and cons of the program in general and the dangerous loophole in the equivalence approach.

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  • Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 1

    12 December, 2018 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This blog post is the first of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. Part 1 discusses key points of the ICIJ investigation on the medical device industry, the FDA’s response, and the implications of this hot-button public debate in the near future.

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  • MDSAP: Guiding Your Company Through the Audit Process

    26 December, 2018 by Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

    Now that you understand what the Medical Device Single Audit Program (MDSAP) is and how it can benefit your medtech company, learn more about MDSAP’s audit process and how to successfully steer your company through the specifics of the journey. This is Part 2 of a three-part blog series about MDSAP.

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  • A Risk-Based Approach to Auditing and Qualifying Suppliers and Vendors

    18 December, 2018 by Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company

    For a manufacturer, qualifying vendors and suppliers can be challenging due to varying philosophies and expectations. To avoid ambiguity and uncertainty, manufacturers should have SOPs and policies for interacting with vendors and suppliers. Audits and quality assurance assessments will go smoother with open and clear channels of communication between all parties that will result in improved compliance.

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  • Wanted: Chief Robotics Officers in Manufacturing

    13 December, 2018 by Cindy Fazzi, Staff Writer, MasterControl

    The concept of working robots has come a long way since Isaac Asimov’s science fiction stories circa 1940s. Today, robots work in Amazon warehouses, streamline the manufacturing process at Adidas, and serve amenities in Crowne Plaza hotels. How long will it take before we start seeing wanted ads for chief robotics officers (CRO) to manage a combined human and robotic workforce?

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  • Santa Embraces Manufacturing Excellence

    6 December, 2018 by Sarah Beale, Staff Writer, MasterControl

    When you’ve got a hard deadline, efficiency is everything and no one knows this better than Santa. While he has the entire year to prepare for December 25th, he’s also preparing up until the last second to ensure he’s got everything ready for the big day. To pull this off, he needs a reliable digital production records solution.

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  • PwC Report Analyzes Health Care Policy Issues

    15 November, 2018 by PricewaterhouseCoopers Health Research Institute

    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.

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

    4 December, 2018 by Arvilla Trag, RAC, Consultant, BioProcess Technology

    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.

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

    8 November, 2018 by Sarah Beale, Staff Writer, MasterControl

    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.

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  • Building an Audit-Ready QMS

    15 November, 2018 by Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company

    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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  • Advancing the Regulatory Profession in Utah

    1 November, 2018 by Robert M. Wolfarth, Chairman, RAPS Utah Chapter

    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.

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  • Risk Management and the Human Species

    6 November, 2018 by Rai Chowdhary, CEO and Founder, The KPI System

    Science has shown that human beings are not immune from making irrational choices when it comes to risk management, even in the life sciences. This can have significant effect on manufacturing processes, and ultimately, patients. Learn how to avoid falling into this trap.

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  • Top 5 Nutraceutical Trends in 2018 - Getting Creative With Protein

    30 October, 2018 by Sarah Beale, Staff Writer, MasterControl

    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.

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  • What's Hiding in Your Labeling Artwork?

    23 October, 2018 by Dan Vuksanovich, Regional Sales Manager, Schlafender Hase

    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.

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