• The Odd Couple - Quality vs. Research

    29 February, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solu

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  • eMDR Conversion and Implementation - Part I

    29 February, 2012 Eugene Reilly, FDA's Center for Devices and Radiological Health

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • The 'Supply Chain' Patient is Sick

    21 February, 2012 Hedley Rees, Biotech PharmaFlow

    Hedley Rees looks at the problems with the pharmaceutical supply chain and questions whether they can be resolved.

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  • The Rising Costs of Clinical Trials

    31 January, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl

    One of the most costly areas of business for any Pharmaceutical or Biotechnology Company has always been clinical research. Now more than ever the cost of bringing a product to market is staggering and as patents on trademark products expire the hope for recovering costs of research get smaller and smaller.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - for Life Science Professionals

    31 January, 2012 David R. Dills, Quality & Compliance Advisor

    Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

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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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  • Is FDA to Blame for Biomedical Industry's Slow Growth

    31 January, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Given the global economic challenges today, it is understandable that the biomedical industry sees lack of funding as a key obstacle in growth. What is surprising is that the industry also sees the FDA and the current regulatory environment as a stumbling block.

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  • MasterControl Presents 'Change Control, a Risk-Based Approach' at MD&M Texas

    31 January, 2012 MasterControl

    MasterControl Inc. will present "Change Control--a Risk-Based Approach" as a workshop at the MD&M Texas 2012 Conference, March 15, 2012, at the Fort Worth Convention Center in Fort Worth, Texas. MasterControl's Kevin Marcus, product manager and medical device expert, and Walt Murray, director of quality and compliance services, will conduct the workshop.

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  • New FDA Report Reveals Barriers to Medical Device Quality

    7 December, 2011 MasterControl

    You may know that the volume of adverse reporting is on the rise. Did you know that recalls have risen slower than adverse events but have matched industry growth? And that in general, critical, life-sustaining devices are responsible for a growing share of adverse event reports, but not of recalls?

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  • Reading the FDA Tea Leaves

    7 December, 2011 John Avellanet, Management Director, Cerulean Associates, LLC

    Adapted from Cerulean's regulatory intelligence monthly newsletter, SmarterCompliance™ (No. 48, Vol. 4, Iss. 12).

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  • What to Expect When They're Inspecting - Part 1

    18 October, 2011 Holly Scott, Biologics Consulting Group, Senior Consultant and Former CBER Consumer Safety Officer and FDA Field Investigator

    The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.

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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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  • 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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  • New Options for Improving Blood Transfusions

    18 October, 2011 MasterControl

    This story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Duke University Medical Center.

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  • Seven Objective-evidence Items the FDA Will Look For

    13 September, 2011 MasterControl

    This article was originally published in the August 2011 edition of EduQuest's publication: EduQuest-ions & Answers.

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  • For Medical Device Professionals - Is Your Executive Management Involved with Quality?

    13 September, 2011 Christine Park, Christine Park & Associates

    We've all heard of the recent FDA decisions to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area. While there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems:

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  • Four 'Dos and Don'ts' for Handling Warning Signs about an Approved Drug

    8 September, 2011 Brian S. Inamine and Michael F. Ruggio, Attorneys and Shareholders, LeClairRyan

    Faced with bad news about an approved drug (e.g. anything from a rise in reports of adverse reactions among patients to FDA notification that a warning letter is in the mail) pharmaceutical companies naturally tend to focus on the crisis at hand: Can this lucrative product stay on the market, or is a recall inevitable? And if the drug can be saved, what can companies do now to help keep it on the market? Such questions must be asked and answered because according to the trade publication, Gold S

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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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  • Seven Pharmaceutical Companies Submit Joint Citizen Petition to FDA

    12 August, 2011 MasterControl

    A recent blog post written by attorney Dara Katcher Levy describes a citizen petition that was recently submitted by seven pharmaceutical companies requesting more clarification regarding off-label use manufacturer-communications. Specifically, as described by Levy, the companies wrote the petition to request more hard-fast rules and information regarding the following four types of off-label use manufacturer-communications:

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  • FDA Introduces New Strategy to Ensure Safety of Imported Products

    14 July, 2011 MasterControl

    If your company or organization is subject to FDA regulations, it's important to know that this month marks the introduction of some new and important changes at the FDA.

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