GxP Lifeline

 

  • Regulatory Changes Top the List of 2019 Med Device Trends to Watch For

    31 January, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    If you belong to the medical device industry, a perfect storm of regulatory changes is heading your way. The changes in Canada and Europe are at the top of a list of developments and trends to watch for this year, according to four medical device experts.

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  • 5 Ways to Digitally Transform Your Supply Chain

    29 January, 2019 by David Butcher, Staff Writer, MasterControl

    Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

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  • Recall Blunders: How to Avoid Them and How to Recover

    29 January, 2019 by James Jardine, Staff Writer, MasterControl

    Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.

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  • Top 5 Shop Floor Safety Tips

    24 January, 2019 by James Jardine, Staff Writer, MasterControl

    Shop floor safety lapses lead to injuries, low morale, lawsuits, damaged reputations and reduced productivity. Learn the top five strategies for optimizing shop floor safety practices and establishing a culture of safety across a manufacturing enterprise.

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  • Costs of Paper: Hard vs. Soft ROI

    23 January, 2019 by Bryant Headley, Sr. Director of Regulatory Affairs and Executive Government Liaison, MasterControl

    Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously provide you with both soft and hard ROI.

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  • 4 Common Pains in Managing Device History Records

    22 January, 2019 by David Butcher, Staff Writer, MasterControl

    In medical device and diagnostic manufacturing, companies must keep a complete and accurate record of each product they produce in the form of a device history record (DHR). The DHR is literally the history of the device, and manufacturers in the business of medical technology face common challenges when using a paper-based or partially electronic system.

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  • Using Sherlock Holmes to Pick a Consultant

    23 January, 2019 by Sarah Beale, Staff Writer, MasterControl

    When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.

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  • Rolling the Dice on Cannabis Manufacturing

    17 January, 2019 by Sarah Beale, Staff Writer, MasterControl

    Cannabis is complicated, with constantly changing legalities surrounding the industry. Companies wanting to enter this market might find the financial forecasts appealing, but they should also be aware of and prepared for the risks of this unique industry.

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  • How Sustainable Manufacturing Can Help the Environment and Your ROI

    16 January, 2019 by Mike Rigert, Staff Writer, MasterControl

    Sustainable manufacturing is no longer just a buzzword that looks good in your company’s annual report. Technology has advanced to the point where implementing sustainable manufacturing best practices can reduce waste and energy use while still delivering the quality, cost-effective products your customers want.

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  • 4 Tips to Improve Your Medical Device Regulatory Submissions

    15 January, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    Regulatory affairs (RA) professionals in the medical device industry essentially want the same thing: to improve their submissions worldwide for a faster time to market. Alex Butler, an industry veteran, has two words for his peers — global approach. He shares some tips for achieving an effective global strategy.

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  • Call and Response: RFPs and Vendor Proposals

    10 January, 2019 by Ray Sison, VP of Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting

    In Part 2 of a pair of articles on pharma companies having a better and more effective vendor selection experience, it’s clear that a thorough request for proposal (RFP) and well-defined vendor selection SOP are essential. By controlling the vendor selection information, you can control the process and negotiate the best deal.

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  • Modernizing Manufacturing With Digital Trends

    9 January, 2019 by Sarah Beale, Staff Writer, MasterControl

    Stagnation is the enemy of most businesses in most industries, making it hard to keep up – especially when it comes to technology. Managers starting to modernize their manufacturing floor should consider how to use that technology to make more products available more quickly with more advancements.

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  • Need Help With Vendor Selection? Don’t Pick Up the Phone Until You Answer 3 Simple Questions

    8 January, 2019 by Ray Sison, VP of Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting

    Vendor selection in pharmaceutical manufacturing and related life sciences sectors is never an easy process. But incorporating comprehensive SOPs that answer three key questions can make for much smoother discussions during the selection process and contract negotiations.

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  • Despite a Focus on Risk Management, Why Do Unthinkable Things Continue to Happen?

    3 January, 2019 by Rod Farrar, Director, Paladin Risk Management Services

    Accidents and errors, in life and in manufacturing more specifically, continue to happen despite heightened levels of risk management and international standards. Find out why time, frequency and probability can’t be factored in to calculate likelihood and learn the key to determining actual risk.

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  • Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

    2 January, 2019 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.

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  • 5 Keys to Helping Your Device Company Gain MDSAP Certification

    2 January, 2019 by Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

    The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.

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  • 3 Things You Need to Know About Industry 5.0

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

    Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.

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  • Champagne: A Staple of Celebration; A Legacy of Quality

    27 December, 2018 by David Jensen, Staff Writer, MasterControl

    Champagne has long been a staple of holidays and momentous occasions. The bubbly beverage is also deeply rooted in culture and tradition. To coincide with the mirth and merriment of the holiday season, this article discusses the rich history of Champagne and how it has become synonymous with quality.

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  • Safety Is the Key to 6S

    20 December, 2018 by Beth Pedersen, Staff Writer, Master Control

    5S, the system of workplace standardization and organization which originated in Japan, has helped countless manufacturers reduce waste and optimize efficiency. Now, a sixth “S” is turning this lean initiative into a centerpiece of corporate culture, making it more about people than profit.

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  • 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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