• Product Development and Clinical Data Quality Management

    MasterControl

    The product research, development and approval road is long, arduous, and costly, especially for pharmaceutical companies that are still reliant on manual processes and paper-based systems.  According to an ongoing study at Tufts (hyperlink -- http://csdd.tufts.edu/About/History.asp), the average cost of bringing a drug to market jumped from $231 million in 1991, to $802 million in 2001, to the current estimate of more than $1 billion.  After a product is successfully launched,

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  • Six New FDA Enforcement Policies: How They Impact You

    Dr. Marla A. Phillips, Director, Med-XU, Xavier University

    On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA's new enforcement strategy. This strategy involves six new policies that went into effect on September 15, 2009. What are the policies and what do they mean to you?

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  • Tools to Circumvent Pitfalls on the Path to Your IND/NDA Milestones

    MasterControl

    PharmaDirections presents a new webinar: Tools to Circumvent Pitfalls on the Path to your IND/NDA Milestones: Avoid risks, surprises and wasted resources with confident pre-clinical and CMC critical path planning.

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  • Things Change - Plan On It

    Denise Robitaille, RABQSA-certified lead assessor, ASQ-certified Quality Auditor and Fellow of the American Society for Quality

    This article was originally published by Quality Digest Magazine.

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  • GxP Lifeline - Medical Device Newsletter

    MasterControl

    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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  • eMDR and Event Problem Code Changes: Are We There Yet?

    MasterControl

    Normally, "are we there yet?" is the annoying question kids, and some adults, ask during a drive to a summer vacation spot. As summer comes to an end, "are we there yet?" is also a good question for your company to consider with regard to two initiatives currently underway at FDA: eMDR and Event Problem Code changes.

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  • FDA Chooses MasterControl's QMS Article

    MasterControl

    MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for the U.S. Food and Drug Administration (FDA). More specifically, the Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM.

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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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  • Compliance Competitive Advantage: Technology-Based Approach for Quality Management

    MasterControl

    Study: Regulated Manufacturers Using Technology-Based Approach to Compliance Gain Competitive Advantage

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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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  • 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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  • The Sentinel Initiative: Will it finally result in postmarket protection and premarket improvement?

    Marci Crane

    In June 2008 FDANews released an article describing CDRH's top priority which according to the article's summary is a "new postmarket initiative." Also according to the summary, postmarket issues "have taken precedence over premarket [issues]" and have garnered "the first-place slot for the center's priorities."1

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  • Improving Your Quality Management System Step-By-Step - For Medical Devices Industry

    MasterControl

    Medical device firms must contend not only with stiff competition in the marketplace, but also with strict FDA regulations and ISO standards. Most medical device companies recognize the importance of an effective and efficient quality management system (QMS) to help gain competitive advantage and ensure regulatory compliance. If your firm is one of those companies, here are some tips for you.Initial AssessmentLet's take the example of Medical Device Company X, which hired a third-party ISO/cGMP-

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  • Medical Device Lifeline - Why Do We Have Repeat Investigations?

    Nathan Conover, Sr. Partner, Pathwise

    Repeat CAPA investigations are arguably one of the largest areas of concern for quality managers today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as 30% of all open investigations- or 1 in every 3. What's going wrong? Why is this happening to so many of us?

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  • Current Political Climate Favors Passage of Drug and Device Accountability Act of 2009

    Sharon Phillips, Marketing Communication Specialist, MasterControl, Inc.

    Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate.

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  • Adverse Event Reports Hit Record High

    Sharon Phillips

    According to FiercePharma, the number of deaths (4,825) and serious injuries (21,000) associated with prescription drugs during the first quarter of this year was higher than it's ever been.1 These numbers represent nearly a threefold increase over the previous quarter, and a 38-percent increase over last year's quarterly average.

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  • The Medical Device Market in Japan: Worth its Weight in Gold?

    Marci Crane

    For medical device makers the device market in Japan is a literal gold mine.

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  • Medical Device - Articles / News

    MasterControl

    It’s been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal CAPA system. Yet, managing a CAPA system remains a major challenge for many manufacturers. Let’s consider a few things that could help you improve your system.By Ken PetersonFull Article

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  • History of Food, Drug, and Cosmetic Act - Did You Know?

    MasterControl

    by: Kevin Bogert, President of GxP Partners, LLC

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