• Product Development and Clinical Data Quality Management


    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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  • Product Risk Management Under ISO 14971:2007 and ICH Q9

    14 June, 2011 John E. Lincoln, J.E. Lincoln and Associates LLC

    Risk management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

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  • 19 Key Elements to Review for Effective Audits

    18 April, 2017 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination o

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  • Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

    18 April, 2017 Kerry Potter, Founder and President of Summit Consulting, Inc.

    What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

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  • Please Don't Call Them CAPAs

    18 April, 2017 Denise Robitaille, RAB-QSA Certified Lead Assessor, Author and ASQ Certified

    I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separa

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  • Transfer, Comparability and Co-validation

    12 August, 2011 Melissa J. Smith, Founder and Principal Consultant for MJQuality Solutions, LLC

    This article provides an overview of the elements of transfer with references to supportive documents that contain more detail on the areas of interest regarding transfer and validation.

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  • Good Clinical Practices and the Top Five GCP Violations in a Clinical Study

    18 April, 2017 Michelle Sceppa, Principal at MSceppa Consulting

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, biologics, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The regulations that provide a platform for the quality of the data are Good Clinical Practices or GCPs.

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  • Submissions Processes with Templates for Microsoft Word®

    18 April, 2017 Antoinette Azevedo

    As regulatory agencies such as the U.S. Food and Drug Administration (FDA), and parallel agencies in Europe, Japan, and Canada, move toward a completely electronic submission environment, tools like templates for Microsoft Word® become increasingly essential to submissions content development processes. Templates can be essential during the preparation of electronic common technical documents, or eCTDs. The eCTD is a standard created by the International Conference on Harmonisation (ICH), a

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  • From the Project Manager's Toolbox: Strategies for eCTD Marketing Application Submissions

    Rachel Cooper, Project Manager, Cato Research Ltd.

    Nothing may invoke fear in the heart of new, or even seasoned, regulatory project managers more than the preparation and submission of a marketing application in eCTD format for their company. At first glance, marketing application submissions can appear to be a tedious effort to manage with hundreds of documents and players, and requires orchestrating intricately detailed timelines and intertwined steps. A successful filing is possible but requires beginning with the end in mind by planning f

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  • SPL R4: The Latest on Electronic Regulatory Submissions

    18 April, 2017 Keith Thomas, Product Strategist and Former Director of R&D, i4i

    As of June 1st, 2009 the FDA will no longer accept Establishment Registrations or Product Listings submitted on paper for human prescription drugs, human over-the-counter drugs, or listed biologics and veterinary medicines. After that date, all such filings must be made electronically through the FDA's electronic submission gateway and encoded in XML, according to the rules set out in the HL7 Structured Product Labeling (SPL) standard and the FDA implementation guide. Medical devices are not c

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  • Document Control Management Software From MasterControl Facilitates Quality Objectives


    Speed-to-market objectives have long driven project management milestones in pharmaceutical/biotech companies. Today, with patent life seemingly shorter, a robust competitive environment, and stricter regulatory reviews, the concept of speed-to-market is being redefined. It’s no longer just about getting new medical technologies to the waiting healthcare community faster.  It’s also about accuracy in terms of how products are defined to regulatory agencies.Challenges that

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  • Speeding Time To Market For Pharmaceutical & Biotechnology Companies

    Antoinette Azevedo, President & CEO, e-SubmissionSolutions.com

    Pharmaceutical, biotechnology and medical device companies that market blockbuster products can earn over $1 billion dollars per year once their products are approved for sale by the United States Food and Drug Administration (FDA). Approval by the FDA can result in rapid approval to market products on a global level. Companies can invest $1 billion dollars or more over the course of the discovery, research, and development phases of their product candidates. Patent protection can be extended

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  • Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval

    18 April, 2017 Mukesh Kumar, PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research, Germantown, MD

    The biggest risk in drug development is failure to convince the FDA that your product meets the requirements for marketing approval. By the time a company files a New Drug Application (NDA), it believes that sufficient evidence is available in support of the marketing approval, based on its understanding of the regulations and requirements. However, about 40% of the NDAs submitted to the FDA are rejected for one or another reason while more than half go through multiple cycles of review adding a

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  • Reducing Human Error on the Manufacturing Floor

    15 June, 2010 MasterControl

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin.

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  • 7 Critical FDA Concepts for Pharmaceuticals Quality Systems


    From the discovery of penicillin in the late 1920s to the breakthrough anti-cholesterol and anti-HIV drugs being manufactured today, the pharmaceutical industry has always been in the front line of developing new technologies. But the industry has yet to fully embrace modern quality systems operations.

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  • Preparing for a Safety Inspection

    12 July, 2011 Steve Jolley, Subject Matter Expert, Global Safety Compliance and Signal Detection

    This article will be published in the September 2011 issue of the Drug Information Journal. Copyright © 2011, Drug Information Association.

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  • Pundits Forecast Pharma's Future

    18 April, 2017 MasterControl

    End of first-quarter economic reports are pouring in and the economic pundits are pondering the industry's performance in 2007 and forecasting the future of pharma in the remainder of 2008.

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  • How Will Personalised Medicine Have an Impact on Clinical Trials?

    Abel Ureta-Vidal, Managing Director, Eagle Genomics Ltd.

    How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharma industry and the patient?

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  • The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies

    31 January, 2012 Dr. Gerhard Neurauter and Dr. Olaf Schoepke - EXTEDO

    The European Medicines Agency (EMA)(3) recently announced a new pharmacovigilance legislation (1, 2), describing how to modernize its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Considering the consequences on information management and business process, pharmaceutical companies have a very short timeline in which to adapt to and implement the initial phase. The attempt to define and establish the "Identification of Medicinal Product

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