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Showing items tagged as pharmaceutical

  • February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    9 February, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

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  • What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    1 February, 2018 by Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl

    It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

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  • January Tip: How to Choose and Use External Consultants

    23 January, 2018 by Jake Walton, Quality Manager

    External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.

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  • 5 Most Common Pharma Form 483 Quagmires & How to Avoid Them

    26 December, 2017 by James Jardine, MasterControl Communications

    See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.

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  • What is Pharmaceutical Quality by Design?

    9 November, 2017 by Beth Pedersen, Staff Writer

    It seems that Quality by Test is well on its way to being a thing of the past, and for good reason. With only one out of every 10 drug products actually making it to market, it is no surprise that pharma companies are increasingly eager to adopt measures to ensure quality and manage risk. Quality by Design (QbD) continues to be a hot topic across the life science industries, and as evidenced by the widespread adoption of QbD among manufacturers, there is no question about its benefits.

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  • Don’t Let These Product Registration Problems Delay Your Time to Market

    7 November, 2017 by Cindy Fazzi, Staff Writer

    The combination of a lengthy process and high cost of drug development is a hard pill to swallow for pharmaceutical companies. It should serve as the biggest motivation for them to find fundamental ways to accelerate their overall time to market.

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  • 6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

    8 August, 2017 Beth Pedersen

    Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers

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  • Keeping Up with the Top Pharma Industry Trends of 2017

    18 May, 2017 James Jardine

    A close look at the key trends that will have the biggest impact on the pharmaceutical industry this year.

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  • Brave New World: The Mutual Recognition of CGMP Inspections

    9 March, 2017 MasterControl

    Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see

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  • 5 Reasons Why Leslie Knope Should Manage Your SOPs

    24 January, 2017 David Jensen, Marketing Communications

    Compliance observations and warning letters regarding standard operating procedures (SOPs)—or the lack of—in life sciences manufacturing facilities are as common as fruitcake during the holidays. How can medical device and pharmaceutical manufacturers hope to reduce the exorbitant number of documentation infractions? Get Leslie Knope to manage your SOPs.

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  • Process Validation Habits You Should Quit Cold Turkey

    22 November, 2016 Lisa Weeks

    It’s that time again. Time to loosen our belts and get ready to eat ourselves into a food coma feasting on hot, delicious gravy-laden turkey. With turkey on the brain, I started wondering about the phrase “going cold turkey” and how it came to mean the act of quitting something (e.g., substance, behavior or habit) suddenly. And more importantly, when we should do it.

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  • Labor Day by the Numbers: Life Sciences & STEM Edition

    1 September, 2016 David Butcher, Staff Writer

    Did you know that science, technology, engineering and mathematics (STEM) job opportunities in the United States are expected to grow 17 percent by 2018? Or that 39 percent of hiring managers believe science and clinical workers are in short supply?

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