• Please Don't Call Them CAPAs

    18 April, 2017 Denise Robitaille, RAB-QSA Certified Lead Assessor, Author and ASQ Certified

    I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separa

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  • Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

    18 April, 2017 Kerry Potter, Founder and President of Summit Consulting, Inc.

    What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

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  • 19 Key Elements to Review for Effective Audits

    18 April, 2017 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination o

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  • The 5 'W's of Quality Agreements

    18 April, 2017 Arvilla Trag, ASQ Certified Quality Auditor, Midwest Consulting Services, Inc.

    What is a Quality Agreement, and what should be included?

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  • Quality Audit - A Tool for Continuous Improvement and Compliance

    18 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

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  • Global Harmonization Task Force Final Document: Standards in the Assessment of Medical Devices

    18 April, 2017 Marci Crane

    The following article is a Q&A regarding the release of the Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices (acknowledged in this article as the RSAMD final document).1 Q: What is the Global Harmonization Task Force (GHTF)? A: The GHTF is a voluntary group that consists of trade association and medical device authorities from the USA, Canada, Europe, Japan and Australia. Q: Who is the authoring group for the RSAMD final document

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  • Overcoming the Top Three Project Management Challenges

    18 April, 2017 MasterControl

    During the course of the development of a new medical device, project managers inevitably come across three major obstacles to efficient project management: regulatory constraints, resource limitations, and on-time delivery. Prevailing over these challenges may have less to do with better planning and improved project execution and more to do with the management systems employed during the product development cycle.

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  • Can Medical Device Manufacturers Speed Innovation and Lower Costs while Increasing Quality?

    18 April, 2017 Daniel R. Matlis, Founder and President of Axendia

    Medical device manufacturers have consistently focused on bringing innovative products to market. To achieve this, most companies have implemented sequential design and manufacturing processes to ensure regulatory compliance and the highest possible quality.

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  • "Two Roads Diverged": Current Issues for the Medical Device Industry

    18 April, 2017 MasterControl

    Riegel vs. MedtronicDonna Riegel, a New York resident, has sued Medtronic, a Minneapolis based medical device maker, on the grounds that a Medtronic catheter device exploded during her husband’s angioplasty procedure and seriously damaged both his kidneys and mental capacity.  Though it was cancer that eventually claimed the life of Mr. Riegel, Donna Riegel’s attorney is suing for $5 million dollars on the grounds of inflicted injuries during the aforementioned procedure.

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  • Virtualization: Taking Advantage of Part 11 to Save Money

    18 April, 2017 John Avellanet, Managing Director, Cerulean Associates LLC

    MasterControl recently interviewed John Avellanet, the founder of the FDA regulatory intelligence and lean compliance program for executives and business owners, SmarterCompliance™, and the Managing Director of Cerulean Associates LLC. He is the author of more than 35 articles on lean compliance, Part 11, and quality systems, a contributing author to the book Best Practices in Biotechnology Business Development, and a frequent speaker with FDA officials.

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  • Navigating the FDA's New Requirements for eCTD Submissions - Pharmaceutical Industry

    18 April, 2017 Antoinette Azevedo, Founder of e-SubmissionSolutions.com

    The United States Food and Drug Administration (FDA) is taking concrete steps to require the submission of all types of regulatory communication in electronic format. Globally, regulatory authorities are all moving to require electronic submission of regulatory communication. The reasons are many but one reason is clear: the public safety responsibilities of the regulators requires significantly faster access to content that can be supported by paper format.

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  • Why the 'Band-Aids' Keep Falling Off

    18 April, 2017 Vivian Bringslimark, President HPIS Consulting, Inc.

    When we cut ourselves, we automatically reach for a Band-Aid®. Why? It stops the bleeding and we can quickly return to whatever we were doing before the accident happened. Without a lot of fuss, we resolve a messy situation and expect the cut to heal in a few days. Having a box of these adhesive strips on hand allows us to reach for them again and again. The danger in applying a Band-Aid so automatically is that we fail to stop and inspect just how deep the wound really is. Maybe it wi

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  • Find Your Place on the Biotech Maturity Model and Make Better IT Decisions

    18 April, 2017 John Postle

    As information technology plays an ever-increasing role in drug discovery and development, emerging biotech firms can better manage their IT spending by using a three-stage maturity model to determine their needs now and in the future.

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  • America Leads the World in Cancer Research Investment

    18 April, 2017 Robyn Barnes

    The Pharmaceutical Research and Manufacturers of America (PhRMA) reports that America's pharmaceutical research and biotechnology companies are the primary source of R&D funding for new medicines, both for projects in their own laboratories and for research licensed from other sectors. Industry-wide spending on research reached a record $58.8 billion in 2007 - nearly double the National Institutes of Health's entire budget - and is a major reason why America leads the world in developing cures

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  • Five Essential Elements of Computerized Systems Used in Clinical Trials

    18 April, 2017 MasterControl

    In a recent statement announcing the FDA’s partnership with Duke University aimed at modernizing clinical trials, Janet Woodcock M.D.—the FDA’s deputy commissioner, chief medical officer, and leader of the Critical Path Initiative—stressed the importance of technological advances in clinical trial processes. “To ensure the safety of clinical trial participants and to improve the health of the public, the clinical research enterprise needs to evolve,” D

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  • FDA's Evolving Civil Money Penalty Authority:Simple Violations Can Lead to Major Costs

    18 April, 2017 Vernessa Pollard, Counsel in the FDA and Healthcare group at Arnold & Porter LLP, and Mahnu Davar, Associate in the FDA and Healthcare group at Arnold & Porter, LLP

    The U.S. Food and Drug Administration (FDA) has several enforcement tools at its disposal, including warning letters, injunctions, seizures and criminal prosecutions. While most industry professionals are familiar with these enforcement tools, FDA's civil money penalty (CMP) provisions may be less familiar to some. In the past five years, CMPs have emerged as an important enforcement tool as Congress has increasingly expanded FDA's authority to impose such penalties. With the expansion of FDA

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  • How Will the FDA's New Clinical Investigations Guidance Affect Pharmaceutical Companies?

    18 April, 2017 MasterControl

    Discusses how the FDA?s new clinical investigations guidance will positively affect pharmaceutical companies in light of recent news on the relationship between FDA and the industry

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  • CGMP Amendment for Finished Pharmaceuticals

    18 April, 2017 MasterControl

    In December 2007, The Food and Drug Administration (FDA) announced amendment to its current Good Manufacturing Practice regulations for finished pharmaceuticals.  They amended the regulations to modernize or toclarify some of the CGMP requirements, as well as harmonize some of theCGMP requirements with those of other foreign regulators and other FDAregulations. These amendments are also consistent with current industrypractice.

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  • An Analysis of Heparin, Accountability and Pre-emption Where Are We Now?

    18 April, 2017 Christine Humphrey, Esq., Fuerst Humphrey Ittleman

    First in a two-part series, (second part)

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