Showing items tagged as Quality

  • Free E-Book: 5 Things to Expect in the Future of Regulatory Compliance

    7 November, 2016 Cindy Fazzi, Staff Writer

    Global health care spending is expected to increase by 4.3 percent until 2019, with biotech drug sales and medical device revenues forecasted to reach $445 billion and $454 billion, respectively, in 2019 (1). Given such growth, what kind of regulatory landscape can you expect? A newly released enhanced e-book offers five forecasts.

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  • How Frances O. Kelsey Blazed a Trail for Women in Regulatory Compliance

    3 November, 2016 Jon Beckstrand, CEO, MasterControl Inc.

    Whether it’s the ibuprofen we take to remedy a headache or the world’s smallest pacemaker approved by the FDA earlier this year, we can rest assured that these medical products passed scientific scrutiny and complied with stringent regulations. We can thank a woman who blazed a trail at the FDA—Frances Oldham Kelsey—for raising the bar in compliance.

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  • 4 Quality Management Tips We Can Get From Time Travel Movies

    20 October, 2016 David Jensen, Marketing Communications MasterControl

    Ever wish you could have a do-over? Wouldn’t it be nice to be able to go back in time to change or undo some event? Or what about going to a future time? Nothing illegal, maybe just to avoid the lines and hassle of getting a ticket to the next episode of Star Wars.

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  • Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

    13 October, 2016 by Ed Rusch, Vice President, Corporate Marketing, Elemica

    Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

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  • Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

    4 October, 2016 by Cindy Fazzi, Editor, MasterControl Insider

    Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

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  • Identifying and Preventing Common Data Integrity Issues

    20 September, 2016 Joanna Gallant, Owner/President, JGTA LLC

    Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.

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  • Is Compliance an Obstacle to Quality?

    15 September, 2016 Daniel Matlis, Founder and President, Axendi

    Can you distribute poor quality products while complying with regulatory requirements? Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

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  • "Hacking" Quality

    13 September, 2016 Peter Holtmann, President & CEO, Exemplar Global Inc.

    Continuing my theme of the future of quality, the ability to see the future could come through some interesting lenses—hacking, for instance.

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  • Free E-Book Depicts a Decade of Change in Life Science Regulatory Compliance

    6 September, 2016 Cindy Fazzi, Staff Writer

    Which came first, the chicken or the egg? This dilemma applies to automation and regulatory compliance. Did the FDA issue 21 CFR Part 11 to encourage technology use? Or did life science companies use technology first—prompting the FDA to develop corresponding regulations?

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  • Why Russia Is an Attractive Market for Clinical Trials

    16 August, 2016 MasterControl

    When you think of countries as candidates for clinical trials, which ones come to mind? North America, Great Britain, France?

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  • Your Suppliers’ Risk Is Your Risk

    14 July, 2016 By Carrie Mantey

    In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.

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  • What Will Quality Look Like in 20 Years?

    12 July, 2016 Peter J. Holtmann, President and CEO, Exemplar Global

    To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”

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  • MasterControl’s Walt Murray Emphasizes “Establishing Design Parameters” at INTERPHEX 2016

    24 June, 2016 Marci Crane, Localization Manager, MasterControl

    INTERPHEX, one of the largest trade shows and combined fairs and exhibitions for the pharmaceutical, biosciences, biotechnology, medical device, and biomedical engineering industries was held last March at the Javits Center in New York, New York. There are 10,000 participants expected every year for INTERPHEX and 2016 was no exception.

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  • Six Steps to Qualifying Suppliers

    16 June, 2016 by Robert Packard, Packard Consulting

    Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

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  • The Dude Abides! 5 Quotes from “The Big Lebowski” that Apply to Quality

    14 June, 2016 Cindy Fazzi, Staff Writer

    “The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.

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  • Revision is Ongoing for ISO 22000 on Food Safety Management

    9 June, 2016 Sandrine Tranchard, Communication Officer for the International Organization for Standardization

    The consequences of unsafe food can be devastating, both for consumers and businesses worldwide. With many of today’s food products repeatedly travelling across national boundaries, ISO 22000 is more essential than ever to the safety of the global food supply chain. Now the standard is being substantially revised to ensure it stays relevant to modern needs.

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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  • The FDA Just Completed Its Inspection...Now What?

    12 May, 2016 David R. Butcher, Marketing Communications, MasterControl

    Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?

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  • Income Tax Myths and Document Control Systems

    5 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    I’ve been reading Steve Berry’s novel, “The Patriot Threat.” The crux of the book is that the 16th Amendment to the Constitution, the one that requires Americans to pay income tax, may be illegal. The story goes that some of the states may have never ratified the Amendment, and some may have ratified a document that didn’t have the same wording as others. (I won’t spoil the mystery by telling you what transpires.)

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