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  • Mobile Medical Apps & FDA Rules: What Is the Latest in 2017?

    17 November, 2017 by Roger Cepeda

    In the world of mobile apps, things change quickly, and it stands to reason that, as mobile phone makers added better processors, cameras, gyroscopes, and accelerometers, software developers followed with new apps that took advantage of the upgrades, perhaps offering apps that the hardware makers hadn’t even considered. Some of those apps did things that were medical in nature, and many of us in the medical device industry asked, “does the FDA regulate that?” The answer, of course, has been changing, and I’ll provide some background plus the latest on the rules, at least as of the date of this article.

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  • 5 Guidelines for Writing a Useful Clinical Monitoring Report

    15 November, 2017 by Brandy Chittester, IMARC Research, Inc.

    A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection. Here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

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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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  • HIPAA Compliance and Data Security Demand Equal Attention

    2 November, 2017 by David Jensen, Staff Writer, MasterControl

    The Health Insurance Portability and Accountability Act (HIPAA) established by the U.S. Department of Health and Human Services (HHS) has been around since 1996. The components of HIPAA cast a wide net over regulations involving insurance coverage, medical records and tax rules. However, rapidly advancing technology and security threats are pointing a spotlight on the Privacy and Security rules that apply to electronic protected health information (ePHI).

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  • Risk Mitigation in Clinical Research: It Starts with Study Startup

    31 October, 2017 by Craig Morgan, goBalto

    For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays.

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  • QA vs. QC, Quality Control vs. Quality Management: What’s the Difference?

    26 October, 2017 by Kimberlee A. Washburn

    In a company organized properly, quality assurance resides independent of manufacturing and operations, and quality control resides within manufacturing and operations. But what is the difference?

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  • How to Become a QP in Europe

    24 October, 2017 by Wolfgang Schmitt

    Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?

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  • Future Trends and Opportunities in Quality Assurance

    19 October, 2017 by David Jensen, Content Marketing Specialist

    It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.

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  • Revisiting CAPA for a More Modern (and Effective) Approach

    17 October, 2017 by Peter Knauer

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

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  • Gottlieb Says FDA Wants to Widen Access to Better Compounded Drugs

    13 October, 2017 by Karla L. Palmer

    We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance on changes in outsourcing facility compounding in the coming months. FDA’s announcement about draft outsourcing guidance is somewhat of a headscratcher, especially considering that a number of anticipated compounding guidance documents and regulations were recently moved to CDER’s regulatory agenda inactive list (here; search "drug").

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  • FY2018 Increasing User Fees Affects Submission Strategy

    11 October, 2017 by Michelle Lott

    Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.

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  • Three Ways to Accelerate Your Lean Journey

    4 October, 2017 by Dan Markovitz, Markovitz Consulting

    I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).

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  • Anticipating Tensions Between Clinical Care and Study Protocol

    3 October, 2017 Laurie Meehan, Social Media Manager; Polaris Compliance Consultants, Inc.

    Protocol trumps practice. This principle seems clear enough, but complying with it is not always as straight-forward as it sounds. Years of practicing medicine has reinforced the way a physician responds to medical situations. But do these responses run counter to the investigational plan? Can a site’s commitment to standard of care affect its ability to meet enrollment targets? There’s a lot to consider.

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  • Canada’s Evolving Regulatory Landscape

    26 September, 2017 Raleigh Malik, PhD, Sr. Scientist; DIA

    Canada’s sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation. However, with health care product innovation comes government oversight and regulations required to ensure safe and effective treatments for the public.

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  • Coping with Scoping a CSV/Part 11 Audit

    21 September, 2017 by Laurie Meehan, Social Media Manager; Polaris Compliance Consultants

    You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.

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  • Supply Chain Risk Management: An Ever-Changing Mosaic

    19 September, 2017 Geary W. Sikich; Logical Management Systems Corp.

    We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability.

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  • Medical Device Firms: 3 Tips for Jumping Over the Dossier-Management Hurdle

    14 September, 2017 by Cindy Fazzi, Staff Writer

    For medical device companies, the ultimate goal is to commercialize their products, usually in more than one market. The road to a successful product launch in multiple markets is full of obstacles and one of the biggest hurdles is dossier management.

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  • Understanding the Use of “Where Appropriate/As Appropriate” Within the ISO 13485:2016 Standard

    12 September, 2017 by Christine Park, Christine Park & Associates

    Historically, the term “where appropriate” and/or “as appropriate” have been implied within the ISO 13485 standards as well as the FDA 21 CFR 820 Quality System Regulations. The FDA has always explained that “as appropriate” means it is appropriate unless you can justify why it isn’t appropriate.

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  • Rise of Digital Health Prompts FDA to Re-examine How It Regulates SAMD

    7 September, 2017 Jeffrey K. Shapiro; Hyman, Phelps, McNamara, P.C.

    When you think about it, FDA's general regulatory paradigm for regulating medical devices has enjoyed a tremendous run. The overarching statutory and regulatory foundation was started in 1976 and largely in place in its current form by 1997. (Think 510(k)/MDR/Part 806 and QSR procedures for the postmarket phase.)

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