• CAPA: Key Stumbling Block for Device Firms

    17 April, 2017 MasterControl

    GE OEC Medical Systems recently signed a consent decree with the FDA because of CGMP deficiencies, including failure to establish and maintain adequate corrective and preventive action procedures. The news that a company this size has a broken CAPA system is shocking. But at the same time, it is not altogether unexpected if you consider inspection trends for this industry.

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  • Three Quality Management Tips to Avoid Death by CAPA - for Medical Devices Industry

    17 April, 2017 Ken Peterson

    It's been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal corrective and preventive action (CAPA) system to monitor and manage the safety complaints associated with their products. Yet, managing a CAPA system remains a major challenge for many manufacturers.A sound CAPA system organizes and evaluates complaints, nonconformances, and other deviations about products and services to improve patient safety. But the problem is: How do you

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  • Postmarket Management Team Restructuring Processes at CDRH

    17 April, 2017 MasterControl

    The safety of medical devices is a major concern for the FDA, manufacturers and consumers. One faulty drug or device can place lives at risk and ruin the public's trust. Recent events involving pharmaceuticals, medical devices, and combination products have heightened public awareness of product safety. The FDA's Center for Devices and Radiological Health ( CDRH ) responded to the public's concern by creating a new management system to improve the postmarket situation.

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  • Patience is a Virtue for Combination Product Manufacturers

    17 April, 2017 Marci Crane

    In a very real sense combination product manufacturers are changing the face of life science research and manufacturing. In fact, the near future may paint the combination products sector as the leading life science industry sector, while products like transdermal patches for depression, dental bone grafting material with a growth factor, absorbable collagen sponges with genetically engineered human protein, or a surgical mesh with antibiotic coating may become more common than their "less compl

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  • Making Medical Products Better, Faster, and Cheaper: What FDA's Critical Path Initiative Means for Consumers

    17 April, 2017 MasterControl

    Q. How do scientific discoveries affect the development of medical products? A. In recent years, there has been an explosion of scientific discoveries made possible through technologies such as genomics, advanced imaging, nanotechnology, and robotics. These scientific advances can help produce more and better medical products—not just drugs, but biologics such as vaccines, and devices such as pacemakers.But the efficiency for scientific discoveries being translated into medical prod

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  • Deadlines or Dead Projects

    17 April, 2017 William Wolenchuk, Jr., Customer Relations Manager/Medical Device Industry, MasterControl, Inc.

    For all medical device companies, managing a project can be a nightmare. Proper planning and managing of a project can make the difference between a successful product and a financial disaster. Most projects start out with good intentions. However, with improper planning up front, the project can quickly fall behind and run over budget for a number of reasons: poor or lack of requirements document; scope creep; long or missed timelines; employee commitment; change control; and tracking the pro

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  • CMS Launches New Competitive Bidding Program for DMEPOS

    17 April, 2017 MasterControl

    The Centers for Medicare and Medicaid Services (CMS) has opened the first round of competitive bidding for suppliers of Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) under a new acquisition program projected to save taxpayers $1 billion annually upon the program's full implementation in 2010.The new competitive acquisition program will initially apply to 10 of the top DMEPOS product categories within the 10 largest Metropolitan Statistical Areas (MSAs), exclud

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  • Gems on REMS

    17 April, 2017 Peter Pitts

    I recently chaired the "Risk Management and Drug Safety Summit" (co-sponsored by the Center for Medicine in the Public Interest, FDA News, and United BioSource Corporation). It was a content-rich experience.

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  • Advantages to Risk-based Validation

    17 April, 2017 David Ade

    Decrease Computer System Validation Time and Costs by Implementing a Risk-based Approach

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  • Benefits of a Risk-Based Approach

    17 April, 2017 David Ade

    By David Ade

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  • Six Ways to Optimize Your Quality Management System to Ensure FDA and ISO Compliance

    17 April, 2017 MasterControl

    MasterControl software can optimize your Quality Management System to help ensure FDA and ISO compliance.

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  • How Soon Can You Get Me That Six-Year-Old Data?

    17 April, 2017 Daniel R. Matlis

    By Daniel R. Matlis

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  • Stagnation vs. Innovation: FDA's Critical Path Initiative

    17 April, 2017 MasterControl

    Americans born in the 1940s marvel at the advances made in modern medicine since their birth. Vaccines, penicillin, antibiotics, CAT scans, the unraveling of the human genome and cancer drugs have led the march of medical progress into the 21st century. And with so many achievements in medicine during the last 70 years, it is not surprising that Americans expect this trend to continue. But such expectations may be unrealistic. The high costs of drug and medical device development are hamperi

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  • How Life Science Companies Can Avoid Pitfalls in System Evaluation

    17 April, 2017 Jim Murrin

    The FDA is decidedly moving toward an electronic environment. Late last year, the agency solicited comments on its continuing effort to transform all regulatory submissions from paper to electronic and its plan to create an electronic platform that would facilitate the exchange of drug safety and other important clinical research information.If you work in the life science industry, there is probably no way to avoid automation in the long run. Not only is FDA policy pointing toward that di

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  • Pharmaceutical Industry’s Transition from Paper-Based to Electronic Processes

    17 April, 2017 MasterControl

    Pharmaceutical Industry’s Transition from Paper-Based to Electronic Processes.

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  • Validating Electronic Spreadsheets or Automated Forms

    17 April, 2017 Louis Rutledge, Manager of Validation Services and Solutions, MasterControl

    Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries. From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel member not familiar with c

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  • Creating Value Solutions Through Assessment and Risk Reduction

    17 April, 2017 Chris Ward and Thomas Menighan, RPH, MBA, SynTegra Solutions

    Auditing is a more formalized assessment process. Whether we are assessing vendors like software developers whose products are used in the automated processes for manufacturing of pharmaceuticals or medical devices or the less technologically driven processes like pharmaceutical distribution channels for supply chain integrity; the process of inspection can help create useful data to support development of technology for specific uses. These audits also stimulate the utilization of technology

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