• FDA Compliance Software

    18 April, 2017 MasterControl

    Companies competing within the rigorous FDA regulated environments know how important attaining and sustaining compliance is to yearly success which can be easily achieved through MasterControl's FDA compliance software. MasterControl Inc. is a leading provider of FDA compliance software, helping hundreds of life science companies around the world realizes their EU regulatory and FDA compliance goals. Our quality management system meets all FDA 21 CFR Part 11 regulations.

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  • Writing and Maintaining SOPs - Sep 09 - B&B Article

    18 April, 2017 MasterControl

    "SOPs! We don't need no stinking SOPs!"

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  • AUG Writing and Maintaining SOPs: Drudgery or Delight?

    18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl

    "SOPs! We don't need no stinking SOPs!"

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  • Failure Investigation: Treating the Root Cause, Not the Symptoms

    18 April, 2017 Karl Vahey, Director of Compliance, International RA/QA, Covidien

    Why should medical device manufacturers perform failure investigations? One reason is that it is a regulatory requirement. The Code of Federal Regulations (21 CFR 820) in areas such as Non-Conforming Product, Corrective and Preventive Action and Complaint Files describes the requirements for failure investigations. Performing effective failure investigations is also good business practice which can lead to reduction in scrap and rework, process improvements and the elimination of recurring issue

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  • How They Did It: Pfizer's Transition from 50 Document Management Systems to One

    18 April, 2017 Craig Barrila, World Wide Head of Information and Records Management, Pfizer, and Beth Boucher, World Wide Head of Global Network Services, Pfizer

    Like many other pharmaceutical companies, Pfizer has been through numerous mergers, acquisitions and divestitures. Two notable ones were the acquisition of Warner Lambert in 2001 and Pharmacia in 2003. The mergers, acquisitions and silo work practices fractured Pfizer's highly regulated and controlled documentation over many sites and systems. This included our GxP Standard Operating Procedures, product labeling, submissions management and trial master file systems.

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  • GCP Compliance Strategies for 2009 - Medical Device Industry

    18 April, 2017 Carl Anderson, Regulatory Affairs and Quality Assurance Consultant, Field of FDA Health Product Approvals including Medical Devices, Drugs and Biologics

    The FDA press release dated April 30, 2008 should have caught the eye of every regulatory affairs and quality assurance professional responsible for compliance to the FDA. "FDA Embarks on Major Hiring Initiative for its Public Health Mission" the press release blared. "Agency will fill more than 1,300 positions within the next several months," it continued. That is more than triple the number of positions the agency filled in fiscal years 2005-20071.

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  • Beyond the Basics - Building Business Value through an Effective Compliance Program

    18 April, 2017 Peter Claude, Pharmaceuticals and Life Sciences Partner, and Jean Sands, Pharmaceuticals and Life Sciences Manager, PricewaterhouseCoopers LLP

    Through the recent overhaul of the AdvaMed Code of Ethics, medical device companies gained the opportunity to use the renewed emphasis on ethics to revamp their approach to compliance. Most companies quickly integrated the updated Code provisions into their compliance policies and trained their employees to follow explicit guidelines about appropriate and inappropriate interactions and arrangements with healthcare professionals. Now they stand ready to take the next steps to build global complia

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  • Human Factors: Why it is Critical in Designing Medical Devices

    18 April, 2017 David Jensen, Staff Writer, MasterControl

    “Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 

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  • Analytical Method Validation: What is Expected?

    17 April, 2017 Michele Piepoli

    The Food and Drug Administration (FDA), International Organization for Standardization (ISO), European and other regulatory authorities have requirements and expectations regarding the performance and documentation of an analytical method validation.

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  • Creating and Auditing a Global Quality System

    17 April, 2017 Nancy Singer, President, Compliance-Alliance

    Medical device and drug firms with multi-national facilities have many challenges. They need to comply with numerous regulatory requirements. To increase the efficiency of their operations, many firms are creating a globally harmonized quality system for their entire organization, and they are using internal and supplier audits to maintain compliance with regulatory requirements.

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  • 'Standard Work' for Problem Solving

    17 April, 2017 Chris Tsai, President of Global Productivity, Inc. and Certified Six Sigma Black Belt

    When problems occur, are they addressed in a planned, consistent, predictable way? Does a simple problem (i.e. transcription error, typo, missing part) receive the same level of rigor as a complex, multi-variate problem? Are the appropriate problem solving team resources involved and do they all have a consistent expectation of roles & responsibilities? If you're a medical device manufacturer, are investigations and the resulting documentation providing the objective evidence needed to demonst

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  • Four Reasons Why You Should Consider Joining the FDA's STED Pilot Program

    17 April, 2017 Matthew M. Lowe

    Wouldn't it be great to launch your next product globally? It certainly makes good business sense. But for medical device manufacturers, this is an unreasonable goal because different countries and geographical regions require different regulatory submission formats. So, a 510(k) that has been cleared by the FDA is not applicable in Australia or France because of unique format requirements in those countries. What this means is that a medical device firm's schedule for product release must be ha

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  • 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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