GxP Lifeline

 

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

    28 June, 2018 by David Jensen, Staff Writer, MasterControl

    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.

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

    26 June, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    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.

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  • What Biotech Startups Need to Do to Slay the Competition

    21 June, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    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.

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  • 2018’s Top Clinical Pharma/Bio Trends to Date

    20 June, 2018 by James Jardine, Staff Writer, MasterControl

    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.

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  • Medtech Startups: How to Survive Cutthroat Competition

    19 June, 2018 by Matthew M. Lowe, Executive Vice President, MasterControl

    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.

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  • What the FDA’s New Ruling Means for Caffeine Supplements

    14 June, 2018 by Sarah Beale, Staff Writer, MasterControl

    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.

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  • Australia Offers Wave of Potential for Pharma, Medical Device Manufacturers

    13 June, 2018 by Mike Rigert, Staff Writer, MasterControl

    Australasia is quickly becoming a hotbed for life sector manufacturers including pharmaceutial and medical device companies from around the globe seeking regulatory approval for their products and other opportunities. Find out why.

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  • Time Management: Walk the Talk, QA Professionals!

    12 June, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    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.

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  • TGA Process for Conformity Assessment in Australia

    7 June, 2018 by Grant Bennett, Senior Consultant and CEO, Brandwood Biomedical

    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.

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  • FDA Backs Cannabis-Based Drug to Treat Kids With Epilepsy

    5 June, 2018 by Marci Crane, Staff Writer, MasterControl

    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.

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

    31 May, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

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

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

    29 May, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    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.

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

    24 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    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.

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  • Ensure Data Integrity With a Proactive Data Management Strategy

    24 July, 2018 by David Jensen, Staff Writer, MasterControl

    Data management technologies continue to evolve and improve the processes for collecting, storing and analyzing data. However, new technology rarely avoids growing pains. One dilemma regulated companies face with technology updates is maintaining data integrity. Regulatory guidelines for data integrity insist that all data and metadata remain intact and unaltered. This is a tall order when companies need to perform a large-scale data migration each time they update their data storage infrastructure. A good approach to effectively manage data and remain compliant with data integrity requirements is to develop a practical data management strategy around data storage and migration.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    22 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    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 first part of a two-part series.

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  • Top Medical Device Trends in Asia-Pacific and Around the World

    15 May, 2018 by Terry Walsh, Director APAC, MasterControl

    The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.

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  • Proving the Effectiveness of Mock FDA Audits

    10 May, 2018 by Patricia Santos-Serrao, Director of Product Strategy, MasterControl

    A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.

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  • Quality Problems: Beyond Root Causes to 'Real Causes'

    8 May, 2018 by David Manalan, Principal, INQC Consulting

    Root cause analysis and corrective actions plans work well for solving quality problems, but how do you prevent quality incidences altogether? You have to dig deeper and investigate what David Manalan dubs the "real root cause."

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  • Why Fraud Control Plans Are Completely Unnecessary

    3 May, 2018 by Rod Farrar, Director, Paladin Risk Management Services

    With risk management, governments and companies often rely on having a fraud control plan. But typically, a risk register is more effective at detecting, responding to and preventing various types of organizational fraud.

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  • Necessity Is the Mother of a Groundbreaking Validation Tool

    26 April, 2018 by Cindy Fazzi, Staff Writer

    It has been proven time and again that necessity is the mother of invention. From the printing press to electric cars, the story is similar. The printing press answered the need for a more rapid dissemination of information during the Renaissance, while the electric car is a response to the need for a zero-emission car today. In regulated environments, the dire need to lighten the software validation burden led to the development of a groundbreaking application.

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