GxP Lifeline

 

  • 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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  • Strategic Design of the Supply Chain: Too Little, Too Late for Pharma?

    24 April, 2018 by Hedley Rees, Managing Consultant, PharmaFlow

    Prevent your supply chain from becoming neglected by strategically designing each link in the chain. The key to a successful supply chain isn't focusing on the endpoint but rather bolstering each location along the way.

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  • Top 5 Pharmaceutical Trends to Keep on the Radar in 2018

    17 April, 2018 by Mike Rigert, Staff Writer, MasterControl

    Get up to speed on key takeaways from what are expected to be some of the most tranformational trends to affect the pharmaceutical industry in 2018. And for further analysis of some of the top trends in pharmaceuticals this year, check out the associated white paper.

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  • Top 5 Trends That Will Shape the Medical Device Industry in 2018

    12 April, 2018 by David Jensen, Staff Writer, MasterControl

    At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.

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  • UK's MHRA Issues Final Guidance on GxP Data Integrity

    19 April, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • Top 5 Up-and-Coming Trends for Nutraceuticals in 2018

    10 April, 2018 by Sarah Beale, Staff Writer, MasterControl

    Business is booming for nutraceuticals as consumers turn to vitamins, minerals, herbs, innovative foods and other natural products to improve their health. The industry has expanded its focus to not just provide natural, clean products but also innovative, high-quality ones. The five biggest trends for 2018 reflect this, bringing new steps and creativity to the product development process.

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  • Complaint Analysis: Don’t Forget the Work You’ve Already Done

    5 April, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This month's tip concerns complaint analysis, and the fact that much of the labor of collecting the information for this quality step has already been recorded in writing during the pre-market phase by quality personnel.

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  • GDPR Deadline Approaches: What Is Expected for Compliance?

    3 April, 2018 by Dave Jensen, Staff Writer, MasterControl

    First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).

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  • A Force for Change: Millennials

    29 March, 2018 by Craig Morgan, Head of Marketing, goBalto

    A look at how the changing makeup of the clinical research workforce, with particular attention to the millenial generation, may present future adjustments and opportunities.

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  • Five Tricks and One Philosophy for ISO 9001:2015 Transition

    27 March, 2018 by Colin Gray, Management System Consultant, Cavendish Scott

    Transition to the new version of ISO 9001:2015 is upon us. Many have put it off for a whole host of reasons, and we are now at a point where we all need to act. Differing opinions exist about how easy or how hard the changes will be, but many factors determine that degree of difficulty.

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  • Creating a Lean Culture of Continuous Improvement

    22 March, 2018 by Jared Evans, Professional Instructor and Lean Process Coach, MasterControl

    When working on my bachelor’s degree, I had a memorable experience in a creativity and problem-solving course. In order to calm the growling of our starving student stomachs, the professor said he would reward us with a treat when we turned in our completed homework assignment at the next class period.

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  • Poll Suggests Automation Could Solve 85% of Your Document Control Issues

    20 March, 2018 by Mike Rigert, Staff Writer, MasterControl

    The sophistication and value-added benefits of automated, integrated document control management tools available to manufacturers in the life sciences has come a long way since software solutions were introduced in the 1980s on 5 1/4-inch floppy disks.

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  • Top 10 Takeaways from MD&M West 2018

    15 March, 2018 by David Jensen, Staff Writer, MasterControl

    I recently attended the 2018 MD&M West conference, Feb. 5 – 7, in Anaheim, California. The three-day event pulled together the medical device industry’s top engineering, design and regulatory compliance experts. This year’s conference covered the most timely and pressing topics, including technology, cybersecurity, design control, digital health and regulatory updates.

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  • Here We Go Again With the Medical Device Excise Tax

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

    When the medical device excise tax was suspended recently, the industry was left with a sense of déjà vu. Between January 2013 and January 2018, the tax was implemented once and frozen twice. How long will this touch-and-go situation continue?

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  • Biosimilars: A Safe and Effective Option for Patients

    8 March, 2018 by Christine Simmon, Executive Director of the Biosimilars Council, a division of the Association for Accessible Medicines

    It is a difficult irony that even as medical breakthroughs and new life-saving and life-extending treatments bring hope to patients and families across the country, it also is getting harder for many to afford these critical medicines. The rapidly rising cost of brand-name biologic medicines, which comprise the vast majority of new therapies in the pipeline, mean they are often inaccessible for America’s patients.

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  • Death by Risk-Based Approach: The Practical Guide to the ISO 13485:2016 Practical Guide, Part 3

    8 March, 2018 by Michelle Lott, Principal and Founder, Lean RAQA Systems, LLC

    This is the third post in the series, “The Practical Guide to the ISO 13485:2016 Practical Guide” for medical devices. This post explores examples and application provided within Practical Guide for the implementation of a “risk-based approach.”

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  • What Improv Comedy Can Teach Us About Communication in Clinical Trials

    1 March, 2018 by Beth Harper, President, Clinical Performance Partners

    A look at how some of the insights behind improv comedy training can help clinical trial teams develop and improve communication and problem-solving skills. It's no laughing matter.

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  • What, No Installation Records?

    27 February, 2018 by Christopher Joseph Devine, Ph.D., President, Devine Guidance International

    Christopher J. Devine delves into the topic of medical device installation recordkeeping, and why proper documentation of this process is essential to successfully installing medtech and avoiding warning letters and other mishaps.

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  • February Tip: Managing Updates to Regulatory Documentation

    22 February, 2018 by Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.

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  • Trend Analysis: A Method for Focusing Resources

    20 February, 2018 by Mark Durivage, American Society of Quality (ASQ) Fellow and Managing Principal Consultant, Quality Systems Compliance

    Probably one of the most significant concerns for anyone responsible for implementing, deploying and maintaining a quality management system is the prioritization of resources. Trend analysis is one technique that can help determine if something has changed with a process (quality, production, or service). Trend analysis can be used to monitor a process, especially non-manufacturing processes such as complaints, nonconformances and deviations to aid in the decision for escalation for corrective and preventive action (CAPA).

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