• 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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  • 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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  • 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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  • 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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  • Medical Device Firms Experiencing 'Death by CAPA?'

    1 March, 2008 MasterControl

    Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process is a major challenge for most medical device companies. This problem can be so overwhelming that an FDA official called it "death by CAPA."Is your CAPA system helping or "killing" your organization? In the next issue, an article by Ken Peterson, senior partner of PathWise Inc., a leading CAPA training and consulting provider, will examine ris

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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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  • 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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  • Assessing the Proposed Changes to the US FDA's 510(k) Programme

    6 November, 2010 Karen M. Becker, PhD, Founder and Chief Executive Officer of Becker & Associates Consulting, Inc.

    Note: This article originally appeared in the September-October issue of Regulatory Affairs Medtech, and was published online at www.regulatoryaffairsmedtech.com on September 8, 2010.

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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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  • 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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  • GxP Lifeline - Medical Device Newsletter


    The GxP Lifeline Medical Device consists of general feature stories, additional articles, a list of conferences, trade shows, and other events for life science professionals as well as a monthly Did You Know piece. For each article, we also include links to related articles and websites.

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  • Is There a Legal Requirement to Have SOPs for GCP in Europe?

    18 October, 2011 Dr. Marie McKenzie Mills MICR, CSci, CBiol, MSB

    Before addressing whether there's a European requirement for Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP), we need to consider whether ICH GCP (i.e. as provided by the International Conference on Harmonisation) remains the international standard following the publication of the Clinical Trials Directive (2001/20/EC) and the GCP Directive (2005/28/EC). Why? Mainly because the Clinical Trials Directive did not explicitly mention ICH GCP, leading to the perennial question o

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  • ISO Standards: Quality Objectives and Quality Dreams

    6 October, 2010 Mark Kaganov, Director of Quality Operations, Quality Works

    Author's Note: This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. The author suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. This article also illustrates ineffectiveness that results from vague and poorly defined quality objectives, and demonstrates how well-structured and documented quality objectives

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  • Improving Data and Content Migration Testing

    David Katzoff, Managing Director of Product Development and Chief Architect for Valiance

    In our previous article we outlined the nature of risks faced by regulated companies undertaking data migrations. We also gave some ideas on how that risk needs to be addressed and mitigated, primarily through the implementation of an appropriate and effective testing strategy. This article aims to continue that discussion and elaborate on what makes an appropriate and effective testing strategy for your particular environment.

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  • Good Clinical Practice: From Review to Application

    18 October, 2011 Rebecca York, Clinical Research Associate, IMARC Research

    As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.

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  • Good and Bad Responses to 483s

    Cathy L. Burgess, Esq., Crowell & Moring, LLP

    Preparing a response to a Form FDA 483 can be a time-consuming and stressful process. It diverts resources from other activities and, if not managed properly, the process can be overwhelming. If a 483 response is well written, factually correct and complete, it will establish that the firm has taken or is in the process of taking appropriate corrective and preventive action. This can allay FDA concerns about the firm's compliance, and reflect positively on the organization. If the response i

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  • Making the Move to Collaborative Work - Feature - GxP Lifeline

    Kate Wrightson Merlino, Senior Technical Editor in the Technical Services Division, nSight

    What is a collaborative work environment? Almost all work has collaborative elements: we work with co-workers, managers, and subordinates in teams, committees, and departments. We use many environments and tools to share information and ideas. While working together is not a new concept, technological advances and shifts in workplace culture have changed the way we work.

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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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  • 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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  • 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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