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  • Regulatory Manager Tip: Making Your Voice Heard at the FDA

    17 July, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    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.

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

    12 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    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.

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

    10 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    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.

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  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    5 July, 2018 by James Jardine, Staff Writer, MasterControl

    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.

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

    3 July, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    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.

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  • 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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  • 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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  • 7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

    18 May, 2018 Ginette Colazzo, President, Ginette M. Collazo Human Reliability Consultancy

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects. Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and GMP enforcement agencies are being more critical of the approach, result, and effectiveness of corrective and preventive actions or CAPAs when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.

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